Design controls in medical devices are a systematic set of methods to carry out the design of medical devices. Medical devices must be developed and manufactured in ways to ensure effectiveness, safety, and compliance.
The main purpose of design control is to ensure product safety and effectiveness, meet user and regulatory traceable documentation, facilitate continuous improvement, and streamline the development of a medical device. Design control is necessary for manufacturers to reduce risks, ensure compliance, and provide the market with high-quality products by adhering to a defined process.
Regulatory agencies like the U.S. FDA and international standards like ISO 13485, which is harmonized with Regulation (EU) 2017/745 (EU MDR), require the use of design controls. To ensure product quality, safety, and compliance, the FDA’s 21 CFR Part 820.30 and ISO 13485:2016 (Clause 7.3) set forth specifications for design controls in medical device development. These regulatory requirements place a strong emphasis on planning, traceability, and comprehensive documentation.
Design control is structured into phases such as user needs, design and development planning, design input, design output, design review, design verification, design validation, design transfer, design changes, and finally, the Design History File (DHF). The main advantages of a strong design control system include its ability to facilitate design reviews, ensure the product meets requirements, guarantee safety and effectiveness, and improve time-to-market.
SimplerQMS offers modern QMS software with robust design control capabilities tailored to meet the needs of medical device companies and applicable regulatory requirements. Book a personalized demo to see how SimplerQMS can streamline your design control processes for medical devices.
What Are Design Controls?
Design controls, specifically design controls in medical devices, as defined in the US FDA Design Control Guidance for Medical Device Manufacturers (1997), are an interrelated set of practices and procedures that are incorporated into the design and development process. These controls ensure that medical devices meet safety requirements and fulfill their intended purpose. They provide a structured approach to ensure that medical devices are safe, effective, and compliant with customer and regulatory requirements while minimizing design risks.
In medical device development, design controls help establish guidelines for documentation, risk management, and testing. Design control identifies and corrects any flaws in design input requirements and aims to ensure that proposed designs meet these requirements. With proper documentation, engineers and relevant personnel can more easily direct the process and make necessary adjustments, increasing the likelihood that the device will be suitable for its intended use.
Design controls are a fundamental element in the regulatory framework for medical devices. In the U.S., the FDA’s Quality System Regulation (QSR) under 21 CFR Part 820 mandates design controls for Class II and III devices to ensure safety and effectiveness through documented processes for planning, inputs, verification, and validation. In Europe, the EU Medical Device Regulation (MDR) 2017/745 incorporates design controls into the conformance assessment process, requiring documentation of clinical evaluations, safety, and performance. Design controls also align with international standards like ISO 13485, which ensures structured design procedures for maintaining product quality and compliance.
Why Are Design Controls Important?
Design controls are essential for ensuring patient safety and guaranteeing medical device performance. They set up protocols that ensure medical devices are safe and effective, and comply with regulatory requirements like the FDA, EU MDR, and ISO. By maintaining strict design standards and ensuring thorough testing and validation, these controls help prevent costly mistakes and recalls.
Historical device failures emphasize the importance of comprehensive design controls. For example, a device marketed as safe that later caused severe infections and fatalities highlights the need for rigorous verification and validation. One notable case, as cited in the U.S. FDA website under medical device recall, is the June 2022 recall of 23,372 HeartWare Ventricular Assist Devices (HVAD) due to battery issues, which posed significant risks of injury or death. This recall, along with the manufacturing costs, demonstrates the financial and safety consequences of inadequate design controls.
What Are the Medical Device Design Control Requirements?
Medical device design control requirements are regulatory guidelines that aim to ensure medical devices are developed to meet customer and regulatory requirements. These requirements are primarily outlined in FDA 21 CFR 820.30, Regulation (EU) 2017/745 (EU MDR), and ISO 13485:2016, as described below.
- FDA 21 CFR Part 820: Section 820.30 of FDA’s 21 CFR Part 820 outlines design controls to ensure that devices satisfy user requirements and regulatory criteria. This section also requires the establishment of Quality System Requirements for medical devices in the United States.
- Regulation (EU) 2017/745 (EU MDR): Comprehensive framework for the production, distribution, and post-market surveillance of medical devices. However, the regulation does not offer detailed guidance on these processes. Compliance instead relies on meeting the “Product Realization” requirements outlined in Section 7 of EN ISO 13485:2016, which sets detailed standards for design, development, production, and service provision.
- ISO 13485:2016: International quality management system (QMS) standard specifically designed for medical device manufacturers. It ensures that design, development, production, installation, and maintenance processes meet customer and regulatory requirements consistently. The European version, EN ISO 13485:2016, harmonizes compliance with EU standards and provides detailed requirements for product realization, including design and development.
Although regional requirements may differ, their main goal is to ensure product quality and safety through organized procedures.
FDA 21 CFR Part 820 Design Control Requirements
FDA 21 CFR Part 820 sets quality system requirements for medical devices in the US, with design controls outlined in section 820.30. Specific requirements include design and development planning, design input, design output, design review, design verification, design validation, design transfer, design changes, and design history files. Compliance involves maintaining detailed documentation, conducting periodic reviews, and ensuring all processes align with regulatory guidelines.
The design control requirements of 21 CFR Part 820.30 are listed below.
- Design and Development Planning: Manufacturers must create and maintain plans that outline design activities, define responsibilities, and describe interactions with other groups. These plans must be reviewed and updated as the design evolves.
- Design Input: Manufacturers must establish procedures to ensure design requirements are appropriate, addressing the device’s intended use, user needs, and patient needs. These requirements must be documented, reviewed, and approved by designated individuals.
- Design Output: Procedures must be in place to define and document design output, ensuring it meets input requirements and includes acceptance criteria. Design output must be reviewed and approved before release.
- Design Review: Formal, documented reviews must be conducted at key stages of the design process, involving all relevant stakeholders. The results, including participants and review details, must be documented in the Design History File (DHF).
- Design Verification: Procedures must be in place to verify that the design output meets the design input requirements. Verification results, including methods, dates, and participants, must be documented in the DHF.
- Design Validation: Validation ensures the device meets user needs and intended uses under actual or simulated conditions, including software validation and risk analysis when appropriate. The results, including methods, dates, and participants, must be documented in the DHF.
- Design Transfer: Manufacturers must ensure the device design is properly translated into production specifications.
- Design Changes: Procedures must be established for identifying, documenting, validating, and approving design changes before implementation.
- Design History File (DHF): A DHF must be maintained for each device, containing records that demonstrate the design was developed by the approved plan and regulatory requirements.
Manufacturers must implement an effective Quality Management System (QMS) that complies with 21 CFR 820 – read more about 21 CFR 820 QMS here.
Regulation (EU) 2017/745 (EU MDR)
The European Union created Regulation (EU) 2017/745, often known as the EU Medical Device Regulation (EU MDR), as a comprehensive regulatory framework to control the production, distribution, and post-market surveillance of medical devices.
Under Article 10.1 of EU MDR, manufacturers are responsible for ensuring their medical devices comply with the regulation. While Article 10.9 requires a Quality Management System (QMS) addressing “product realization,” which states that “The quality management system shall address… (g) product realization, including planning, design, development, production and service provision”, the regulation lacks detailed guidance on these processes. Instead, compliance relies on meeting the “Product Realization” requirements outlined in Section 7 of EN ISO 13485:2016, which provides detailed standards for design, development, production, and service provision.
To meet EU MDR requirements, manufacturers must have a robust Quality Management System (QMS) aligned with ISO 13485. Learn more about EU MDR-compliant QMS here.
ISO 13485 Design Control Requirements
ISO 13485 is an international quality management system (QMS) standard that is created especially for companies that make medical devices. It describes the prerequisites for an all-encompassing quality system that guarantees that medical device design, development, manufacturing, installation, and maintenance continuously satisfy client and regulatory criteria.
EN ISO 13485:2016 is harmonized with EU regulations and specifies requirements for regulatory purposes, including design and development.
Section 7.3 of EN ISO 13485 details product realization requirements, focusing on design controls.
A summary of Section 7.3: Design and Development in EN ISO 13485:2016 is listed below.
- Planning of Product Realization (7.1): Develop and control product realization processes systematically by defining quality objectives, identifying resource requirements, establishing verification and validation activities, and ensuring traceability throughout the process.
- Customer-Related Processes (7.2): Identify and review customer, regulatory, and patient requirements, translating them into clear design and manufacturing specifications while maintaining effective customer communication.
- Design and Development (7.3): Use a structured process to convert user and regulatory requirements into product specifications, integrating risk management, documented reviews, verification, validation, and control of design changes.
- Purchasing (7.4): Ensure purchased materials meet specifications by evaluating and monitoring suppliers. Maintain supplier records and inspect incoming components for compliance.
- Production and Service Provision (7.5): Control manufacturing processes with validated procedures, cleanliness, and traceability and extend these controls to servicing and maintenance to maintain product quality.
- Control of Monitoring and Measuring Equipment (7.6): Calibrate and maintain equipment to ensure accurate and reliable measurement data, keeping calibration records and ensuring traceability of critical measurements.
The ISO 13485 section 7 ensures a comprehensive approach to maintaining quality throughout the product lifecycle. Key steps include creating design plans, defining inputs and outputs, managing design changes, performing verification and validation, maintaining documents and records relevant to the product design, and ongoing post-market surveillance. These actions ensure the product meets safety, regulatory, and user requirements while preparing the company for regulatory approvals and audits, ensuring the launch of safe, effective medical devices.
To comply with ISO 13485:2016, manufacturers must establish a Quality Management System (QMS) in alignment with the standard – explore more details about ISO 13485 QMS here.
What Is the Difference Between ISO 13485 and 21 CFR 820 Design Control Requirements?
The difference between ISO 13485 and FDA 21 CFR 820 is they differ in purpose, country of application, terminologies used, and specific requirements.
While both emphasize design control requirements to ensure safe and effective devices the detailed comparison depending on its regulatory scope, terminologies, and country of application is outlined in the table below.
| Aspect | FDA 21 CFR 820 | ISO 13485 |
|---|---|---|
| Regulatory Scope | A legally enforceable rule issued by the U.S. FDA for all medical devices sold in the United States. Non-compliance can lead to enforcement actions, including warning letters, fines, or product seizures. | An internationally recognized standard for quality management systems for medical devices. Can be used for compliance with the EU MDR and CE certification. |
| Terminologies | Provides precise guidelines on what documents and paperwork need to be kept and maintained. Explain in full the design control aspects found in §820.30, such as design inputs, outputs, a Design History File (DHF), verification, validation, review, transfer, and revisions. | Offers a framework for design and development processes. Demands thorough records that achieve the same goals as DHF but do not require a specific file name. |
| Risk Management | Promotes a risk-based strategy. The FDA integrates risk management using the industry’s best practices and guideline publications. | Frequently referencing ISO 14971 (Application of risk management to medical devices) and places a strong emphasis on risk management throughout design and development. |
| Country of Application | US-specific and necessary for market entry in the US. | Widely recognized and acknowledged internationally. |
| Documentation Requirements | Specifically requires a Design History File (DHF) that records the full lifecycle of the design and adherence to predetermined design controls. | Does not specifically use the term “Design History File” or DHF, but it does need controlled, documented processes and records for design and development, verification, and validation. |
Furthermore, the table below compares the clauses under the FDA 21 CFR 820.30 to ones under the ISO 13485:2016 Section 7.3 related to design controls.
| FDA 21 CFR 820.30 – Design Control | ISO 13485:2016 Section 7.3 – Design and Development |
|---|---|
| (a) General | 7.3.1 General |
| (b) Design and development planning | 7.3.2 Design and development planning |
| (c) Design input | 7.3.3 Design and development inputs |
| (d) Design output | 7.3.4 Design and development outputs |
| (e) Design review | 7.3.5 Design and development review |
| (f) Design verification | 7.3.6 Design and development verification |
| (g) Design validation | 7.3.7 Design and development validation |
| (h) Design transfer | 7.3.8 Design and development transfer |
| (i) Design changes | 7.3.9 Design and development changes |
| (j) Design history file | 7.3.10 Design and development files |
Harmonization efforts between the two standards have been established. In 2024, the final rule from the FDA has revised part 820 to be titled Quality Management System Regulation (QMSR). The FDA uses the term “Quality System (QS) Regulation” or “QS regulation,” and wherever possible, the FDA has used the terms “QS regulation” and “QMSR.” The rule modifies the regulation’s title and clarifies expectations and concepts used in ISO 13485. These changes guarantee that other relevant FDA standards will be consistent with the integration of ISO 13485.
The new FDA rule will be published in the Federal Register and will take effect two years later. In the meanwhile, manufacturers must adhere to the QS regulation for manufacturers who want to sell in the United States. The FDA will start enforcing the QMSR regulations by the year 2026.
How Does the Design Control Process Work?
The design control process involves systematic steps like planning, input definition, output monitoring to confirm the design meets the inputs, design review, verification, and validation. After validation, the design is transferred to manufacturing, where the production of medical devices is done.
There are various approaches for implementing design control in medical device design development. This includes stage-gate frameworks, waterfall or agile-inspired models, risk-based methodologies aligned with ISO 14971, and thorough documentation practices, including maintaining a comprehensive Design History File (DHF).
What Are the Design Control Phases?
There are nine (9) design control phases listed below.
- User Needs Phase: Involves identifying stakeholder requirements through research and analysis, converting them into measurable design inputs, integrating risk management per ISO 14971, and creating a comprehensive user needs document to ensure traceability and alignment throughout the design process.
- Design and Development Planning: This phase defines project goals, scope, responsibilities, milestones, and resources to ensure a clear roadmap for design and development, with regulatory requirements ensuring compliance through proper documentation.
- Design Inputs: Translate stakeholder needs into measurable specifications, ensuring the device meets its intended purpose and complies with regulatory and safety standards.
- Design Outputs: Focus on creating specifications that meet input requirements and include deliverables such as technical drawings, ensuring compliance with regulatory and manufacturing constraints.
- Design Review: This formal evaluation process ensures that design outputs align with requirements and identify any necessary actions, with documented reviews to confirm compliance.
- Design Verification: Confirms that the design outputs meet the specified input requirements through testing and documentation of results to ensure technical compliance.
- Design Validation: Ensures the final product meets user needs and performs as intended under real-world conditions, with documentation verifying its effectiveness.
- Design Transfer: This phase ensures the device is correctly transferred from design to production, confirming that manufacturing processes maintain product quality and specifications.
- Design Changes: Design changes are managed to ensure modifications do not negatively impact safety or performance, with proper documentation, validation, and approval procedures in place.
The medical device design control flowchart below illustrates the design control process by outlining all design control phases and incorporating the waterfall methodology.
User Needs Phase
The user needs phase is the initial stage of design control. In this phase, one identifies the essential functions and requirements of the device.
First, identification of stakeholders is involved so that you can understand the specific needs and requirements. With an emphasis on functionality, usability, safety, and performance, this knowledge is acquired through surveys, clinical observations, market research, interviews, and competition analysis.
After that, these needs are converted into quantifiable design input requirements, which are then ranked according to regulatory expectations and criticality. By evaluating possible risks, such as negative reactions, and recording these risks in accordance with ISO 14971 standards, risk management is integrated.
Finally, a comprehensive user needs document is created to summarize stakeholder input and requirements, ensuring traceability and alignment throughout the design process.
Design and Development Planning
Design and development planning is the next step after the user needs phase. The design and development planning phase defines project goals and scope.
During alignment among stakeholders on the scope and project goal, setting responsibilities, milestones, deliverables, and resource allocation is essential. Methods for updating the plan and establishing timelines ensure a clear roadmap during the design and development planning stage.
Regulatory requirements like ISO 13485:2016 (Section 7.3.2) and FDA 21 CFR 820.30(b) require this plan to demonstrate compliance.
The FDA 21 CFR 820.30 defines the Design and Development Planning phase in subsection (b) as:
“Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process.”
In ISO 13485:2016 Section 7.3.2 Design and development planning emphasizes the need for a structured and controlled approach to product design and development. Organizations must establish and maintain up-to-date planning documents as the project progresses. This ensures that each phase of design and development is clearly defined, monitored, and aligned with relevant requirements and resources.
The outcome of this phase is a documented and approved design and development plan that outlines how the project will proceed.
Design Inputs
Design inputs focus on outlining the precise features of the medical device. During this phase, it must highlight the functions and capabilities of the device. Inputs translate these into measurable criteria or specifications that guide the design process.
Regulatory bodies emphasize the importance of well-documented design inputs.
FDA 21 CFR 820.30(c) mentions, “Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented”.
ISO 13485 Section 7.3.3 Design and development inputs require organizations to identify and document all key requirements that affect product design and development, such as functional, performance, usability, safety, regulatory, risk management considerations, and insights from similar designs, as well as any other essential requirements.
Design Outputs
Design outputs center around developing specifications and processes. Outputs ensure that resulting designs accurately reflect and fulfill input requirements.
The outcomes of the design work are recorded and completed during the design outputs phase of the design control process.
Product deliverables are created to define the medical device’s key attributes, including the following.
- Physical characteristics (dimensions, weight, and materials)
- Functional specifications (operating parameters and performance requirements)
- Software components (source code, algorithms, and architecture), and packaging and labeling (instructions, warnings, and regulatory symbols).
These deliverables are finalized with consideration of regulatory and manufacturing constraints to ensure compliance and feasibility.
It is important to remember to maintain controlled documents within the Design History File (DHF) or equivalent repositories, including examples like Device Master Records (DMRs) for manufacturing and test protocols and reports for verification and validation during this phase.
FDA 21 CFR 820.30(d) requires that “each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified. Design output shall be documented, reviewed, and approved before release. The approval, including the date and signature of the individual(s) approving the output, shall be documented”.
ISO 13485 Section 7.3.4 Design and development outputs mandate documented design and development outputs shall fulfill all design and development input requirements. Design and development outputs should provide information necessary for purchasing, production, and service activities, contain or reference product acceptance criteria, and specify essential product characteristics related to safe and proper use. These documented outputs ensure that the final product aligns with initial design inputs and regulatory expectations and that records of the design and development shall be maintained.
What Is the Difference Between Design Input and Design Output?
The main difference between design input and output is the stage of development and the phase target. Design input specifies requirements and design output relates to the deliverables meeting these requirements. For example, the user needs shape inputs, while technical drawings serve as outputs.
Design Review
Design review involves formal evaluations at various stages of the design to ensure adherence to inputs. This review involves cross-functional teams for comprehensive insights or evaluation.
FDA (21 CFR 820.30(e) requires that “Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development. The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the DHF).”.
As per ISO 13485 Section 7.3.5 Design and development review, organizations are required to conduct systematic reviews of design and development at designated stages according to documented plans. These reviews focus on confirming that design results satisfy the specified requirements and on determining any actions needed. They must include representatives from the relevant design stage as well as other expert personnel. Detailed records must be kept, showing which design was reviewed, who took part, when the review occurred, and any recommended actions.
The outcome of the design review is finding any problems or gaps in the design, solutions that can be implemented to solve issues that have been discovered, updated design documentation that takes decisions and modifications into account, and permission to move on to the following stage of development.
Design Verification
Design verification is the phase to confirm that design outputs meet design input requirements. In order to guarantee the product’s quality, safety, and adherence to regulatory and customer requirements, this design verification is crucial. Documentation of activities through a comprehensive verification report is done to confirm technical compliance with the design criteria.
The regulatory framework of design verification is mentioned in FDA 21 CFR 820 and ISO 13485.
FDA 21 CFR 820.30(f) requires“Each manufacturer shall establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the design input requirements. The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the DHF.”
ISO 13485 Section 7.3.6 Design and development verification states that organizations are required to verify that design and development outputs fulfill the specified input requirements by following documented plans. These plans must outline the verification methods, acceptance criteria, and relevant statistical techniques, including the rationale for sample size. If the device is intended to connect or interface with other medical devices, verification must show that the design outputs align with the input requirements in those conditions. Records of verification results, conclusions, and any necessary actions must be maintained.
Design Validation
Design validation is the final check that ensures that the final product aligns with user needs and intended functionality in actual conditions or real-life suitability. Clinical evaluations and end-user feedback are essential methods for this confirmation.
The regulatory framework that supports design validation is as follows.
FDA 21 CFR 820.30(g) requires “Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF.”
According to ISO 13485, Section 7.3.7 Design and development validation must follow planned and documented arrangements to confirm that the product fulfills its intended use or application requirements. Validation plans should detail the methods, acceptance criteria, and any statistical approaches, including the rationale for sample size.
Validation is conducted on representative products, such as initial production units or equivalents, with the basis for their selection recorded. If the product is intended to connect or interface with other devices, validation must confirm that all relevant requirements are met in those conditions.
In addition, validation must be completed before the design is transferred to production, and records of the results, conclusions, and any necessary actions must be maintained.
The design validation phase is a way to validate that the risk control measures that were identified early in the design phase are in place and successful.
A key goal of design and development validation is to confirm that the medical device meets user requirements and is suitable for its intended use. This validation activity is supported by a thorough validation report to prove that the medical device indeed meets the user requirements and specifications.
Another is identifying any risks that still exist with the medical device and recording the mitigation strategies. This phase approves moving forward with design transfer and production.
What Is the Difference Between Design Verification and Design Validation?
Design verification and design validation differ primarily in their areas of objectives, focus, and methods. The main difference is verification confirms that the device was built according to the design specifications on the design inputs, whereas design validation validates that the design is acting based on the intended use that is tested in different environments.
Design verification and design validation are different design control phases that are crucial steps that guarantee the medical device satisfies specifications and is suitable for its intended application. The table below summarizes the main differences between design verification and validation.
| Aspect | Design Verification | Design Validation |
|---|---|---|
| Objective | Verifies that design outputs are in line with design input | Ensures that the medical device meets the manufacturer’s intended use and specified requirements |
| Focus | Ensures specifications are accurate and compliant with design requirements | Validates functionality, usability, and performance |
| Scope/Regulatory Basis | Ensures the design was accurately developed based on the design input | Focuses on whether the correct product was designed, addresses user needs, and ensures all risks have been mitigated |
| Methods and Environment | Conducts inspections, testing, analysis, and requirement comparisons in controlled or simulated environments | Includes usability testing, clinical evaluations, and real-world trials or closely simulated conditions |
| Documentation | Verification Report | Validation Report |
| Timing | Conducted during and after design output development | Conducted after verification and before design transfer |
| Example | Testing the software code of a medical device against predefined requirements to ensure proper functionality | Simulating real-world conditions to test the device’s performance under expected/anticipated stresses |
In the process of developing medical devices, design verification and design validations have main differences and together, they create a complementary approach to guarantee confirmed efficacy, quality, and safety throughout the development cycle.
Design Transfer
Design transfer transitions the product from the design stage to the manufacturing phase, ensuring the design is accurately implemented in production.
The regulatory framework supports design transfer in the following sections of FDA and ISO.
FDA 21 CFR 820.30(h) mandates, “Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.”
ISO 13485 Section 7.3.8 Design and development transfer has a provision that organizations are required to document procedures for transferring design and development outputs to manufacturing. These procedures must verify that the outputs are fit for manufacturing before being finalized as production specifications and confirm that production capabilities can fulfill product requirements. All results and conclusions from this transfer process must be recorded.
Design Changes
Design changes refer to the management of modifications after the initial design phase, during and throughout any point during the product lifecycle, including post-development of a medical device. By controlling design changes, this phase prevents negative impacts on safety and functionality.
FDA 21 CFR 820.30(i) states that “Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.”
ISO 13485 Section 7.3.9 Control of design and development changes specifies that organizations must maintain documented procedures to control design and development changes, assessing the impact on function, performance, usability, safety, and regulatory requirements. Changes must be identified and, before implementation, reviewed, verified, validated (when appropriate), and approved. The review process should include an evaluation of how these changes affect existing parts, products already in process or delivered, risk management inputs and outputs, and other product realization processes. Records of all changes, reviews, and any necessary actions must be kept.
Design History File (DHF)
Design History File (DHF) is a compilation of records demonstrating compliance with the design control. These records are essential for audits and inspections. Additionally, the design history file is required by regulatory agencies such as the FDA.
FDA 21 CFR 820.30(j) requires that “Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.”
Meanwhile, ISO 13485 does not specifically use the term “Design History File”. However, Section 7.3, does direct that design and development procedures be recorded in a manner that guarantees compliance and traceability. In keeping with the idea of a DHF, this entails keeping thorough records of the design and development operations. The DHF must contain or reference all records necessary to demonstrate that the design was developed in accordance with the approved design plan and complies with regulatory requirements.
Section 7.3.10 Design and development files states that organizations must maintain a design and development file for each medical device type or family, which includes or references all records demonstrating compliance with design and development requirements and any associated changes.
How Do Design Controls Ensure Traceability?
Design controls ensure traceability by systematically documenting every phase of the medical device design process, from inputs and outputs to modifications, verification, and validation. This organized documentation creates a crucial record that links each design decision, change, and verification step to the initial specifications.
Full traceability through design controls offers an advantage in regulatory compliance. It maintains a transparent, documented linkage between each step of the design phase specifications. By guaranteeing that every design choice, modification, and test is recorded and supported by evidence, traceability makes it easy to prove that the medical device design satisfies the necessary specifications and requirements.
Furthermore, by thoroughly documenting design decisions, modifications, and results, full traceability helps connect responsibility to specific departments and personnel involved in the design process. It also helps the quality assurance department by ensuring every design stage is assessed, upholding product safety, quality, and risk mitigation. Additionally, traceability makes records easily accessible, streamlining audits and inspections. Finally, it supports post-market surveillance, enabling manufacturers to detect and address design-related issues after the product is launched.
Several tools, such as the design control traceability matrix, help achieve effective traceability by tracking relationships between design inputs, outputs, verification, validation, and changes, ensuring all decisions are documented and traceable.
What Is a Design Control Traceability Matrix?
A design control traceability matrix (DCTM) is a table or spreadsheet that links design inputs, outputs, and test results for verification and validation activities. The matrix’s main purpose is to provide an overview and link to the requirements being addressed.
In creating and maintaining DCTM, one can use Microsoft Excel, Google Sheets, or specialized software like Design Control Systems (DCS). The matrix columns can have design input, design output, verification method, validation method, design review, design changes, and regulatory requirements.
The design control traceability matrix example (blank) template is shown below.
| Design Input | Design Output | Verification Method | Validation Method | Design Review | Design Changes | Equivalent Requirement |
|---|---|---|---|---|---|---|
What Are the Advantages of an Effective Design Control System?
An effective Design Control System (DCS) enables medical device manufacturers to develop safe, effective, and compliant products while upholding high standards of quality, efficiency, and risk management throughout the device lifecycle.
The key benefits of having an effective design control system are listed below.
- Capability of design review: An organized DCS enhances collaboration among teams, ensuring thorough product reviews through clear communication and departmental alignment.
- Ensure the product is produced according to specifications and other applicable requirements: A robust DCS defines and follows structured phases of design control, from input to output, verification, validation, manufacturing, and product launch.
- Guarantee that the product is safe, effective, and suitable for its intended use: DCS reduces human error, guarantees thorough documentation, and offers transparency throughout the design and development phases by automating and optimizing these procedures. These features are essential for guaranteeing the product’s safety, efficacy, and suitability.
- Compliance with regulatory requirements and audits: DCS offers centralized documentation, traceability, and automation across the design control phases, which helps the organization to be audit/inspection ready.
What Is the Role of Design Control Software?
Design control software plays a significant role in streamlining the design and development process for medical devices. This kind of software offers a centralized platform for managing all design control aspects, helping ensure adherence to regulations and standards, including FDA 21 CFR 820, EU MDR, and ISO 13485.
Design control software is often included in modern QMS software solutions. These solutions have features that effectively manage and control design control documents throughout the different design control phases. SimplerQMS offers QMS software that has design control capabilities, supporting compliance across all QMS processes in the medical device industry.
SimplerQMS software supports all QMS processes, including document control, training management, nonconformance handling, and corrective and preventive actions (CAPA), among many other QMS modules, aside from the design control.
SimplerQMS helps ensure compliance by supporting design control requirements outlined in FDA 21 CFR 820.30, EU MDR (Regulation (EU) 2017/745), and ISO 13485:2016, assisting companies in meeting design control requirements and streamlining other QMS processes.
To know more about this QMS software and how it can streamline your processes, consider booking a demo.
