Medical Device Quality Management System (QMS)

A Medical Device Quality Management System (QMS) is a structured framework of policies, processes, and procedures designed to ensure that medical devices consistently meet safety, quality, and regulatory requirements throughout their entire lifecycle.

Medical device manufacturers must implement a QMS that meets international regulatory requirements to obtain market approval and minimize risks.

The primary regulatory requirements for a medical device QMS include FDA 21 CFR Part 820 in the United States, ISO 13485:2016 globally, EU MDR (2017/745) for general medical devices, and EU IVDR (2017/746) for in vitro diagnostic devices.

A medical device QMS consists of several core processes, including document control, change management, training management, nonconformance management, and complaint handling. Additional essential components include CAPA management, audit management, supplier management, equipment management, product management, and post-market surveillance.

To establish and implement a medical device QMS, companies should follow key steps such as understanding regulatory requirements and defining quality objectives and policies. Followed by developing a quality manual, implementing document and record control, and establishing SOPs and work instructions. Moreover, training employees, conducting internal audits, and ensuring CAPA and PMS compliance.

Utilizing an electronic Quality Management System (eQMS) can streamline QMS processes, improve traceability, and ensure compliance with applicable requirements.

SimplerQMS offers comprehensive QMS software for medical device companies and supports compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR, and EU IVDR.

What Is a Medical Device Quality Management System (QMS)?

A medical device quality management system (QMS) is a structured framework that documents the policies, processes, and procedures applied throughout a medical device’s lifecycle.

The primary purpose of medical device QMS is to streamline processes and help ensure compliance, product safety, and quality. Furthermore, medical device QMS is a tool to demonstrate conformity with pertinent requirements such as FDA 21 CFR Part 820, EU MDR, EU MDR, and ISO 13485 and in turn gain market access.

From design control and risk management to supplier evaluation and post-market surveillance, a medical device QMS can oversee each step of product development and commercialization. Medical device QMS helps guarantee controlled and documented procedures that lower errors in products and promote product safety and ongoing improvement.

Some of the main QMS processes for medical device manufacturers include document control, change control, employee training, audit management, CAPA, supplier management, risk management, and complaint handling.

Costly recalls, fines from the government, and harm to patients or the company’s reputation can be avoided or minimized occurrence by establishing and implementing an efficient QMS.  Additionally, QMS increases productivity, cultivates a culture of quality throughout the organization, and increases confidence among stakeholders, including consumers and regulators.

A quality management system is essential for manufacturers intending to sell medical devices in international markets, as they must implement and maintain a QMS that complies with relevant international and national standards, guidelines, and regulations.

The format of a QMS varies based on an organization’s size, complexity, and available resources. Some companies use paper-based systems, while others adopt electronic quality management systems (eQMS) for improved traceability, automation, and efficiency. Quality management software, such as SimplerQMS, helps implement medical device QMS by streamlining processes and helping ensure compliance.

What Is the Documentation Structure of a Medical Device QMS?

The standard structure of documentation in a medical device QMS is listed below.

• Quality Manual: The quality manual is a high-level document defining the structure of the QMS, its scope, organizational framework, and core processes. For example, a document demonstrating compliance with ISO 13485 or FDA 21 CFR Part 820, outlines the governing principles of the QMS.
• Policies: The QMS policies, such as quality policy and company policy, and objectives reflect the organization’s commitment to quality, risk management, and regulatory compliance. A policy statement aligning with global regulations such as the EU Medical Device Regulation (MDR) (2017/745) or US FDA Quality System Regulation (QSR) (21 CFR Part 820).
• Procedures or Standard Operating Procedures (SOPs): SOPs provide a structured framework for executing consistent and compliant quality processes within the QMS structure. SOPs in the medical device industry in general have Document Control SOP, Design Control SOP, Risk Management SOP, CAPA SOP, Supplier Control SOP, and more.
• Work Instructions (WIs): Work Instructions (WIs) provide task-specific guidance, ensuring precise execution of standardized procedures. WIs are often child documents from a parent’s SOP.
• Records: Records such as forms, logs, and reports serve as documented evidence of compliance, traceability, and quality assurance within the QMS structure. For example, records could include calibration records, training, maintenance, and technical records depending on applicable requirements for example Device History Record (DHR), Device Master Record (DMR) or Technical File, and Design History File (DHF).

The standard structure of documentation in a medical device QMS is shown in the image below.

What Are the Requirements for a Medical Device QMS?

The most common requirements for a medical device QMS are listed below.

• FDA 21 CFR Part 820 Quality System Regulation (QSR): The FDA 21 CFR Part 820 is a US Food and Drug Administration (FDA) regulation for medical device manufacturers. FDA 21 CFR Part 820 mandates establishing and maintaining a QMS that ensures medical device safety, effectiveness, and compliance.
• ISO 13485:2016 International QMS Standard for Medical Devices: ISO 13485:2016 is an internationally recognized standard that specifies requirements for a comprehensive QMS in the medical device industry. ISO 13485:2016 defines the requirements for a comprehensive medical device QMS, ensuring regulatory compliance across global markets.
• European Union Medical Device Regulation (EU MDR 2017/745): EU MDR is a regulation that governs medical devices marketed in the European Union. The EU MDR has requirements for enforcing QMS, clinical evaluation, and PMS.
• European Union In Vitro Diagnostic Medical Device Regulation (EU IVDR 2017/746): The EU IVDR (2017/746) is a regulation that applies to vitro diagnostic medical devices marketed in the EU. EU IVDR enforces clinical evidence requirements, PMS monitoring, and traceability via Unique Device Identification (UDI).

FDA 21 CFR Part 820: Quality System Regulation (QSR)

The 21 CFR Part 820 regulation, enforced by the US FDA, defines Quality System Regulation (QSR) requirements for medical device manufacturers.

21 CFR Part 820 establishes minimum requirements for a medical device QMS to ensure product safety and effectiveness.

Compliance with 21 CFR Part 820 is mandatory for manufacturers seeking market approval in the United States. Key requirements include design controls, production and process controls, and complaint handling.

ISO 13485:2016

ISO 13485:2016 is an internationally recognized QMS standard for medical device manufacturers. ISO 13485:2016 defines requirements for the design, production, installation, and servicing of medical devices. It helps ensure compliance with regulatory frameworks such as EU MDR and FDA 21 CFR Part 820.

The primary objective of ISO 13485:2016 is to establish a risk-based approach to quality management, ensuring consistency in product quality, regulatory compliance, risk management integration, traceability, and continuous process improvement.

ISO 13485:2016 applies to medical device manufacturers, suppliers, service providers, and organizations involved in products that function as or within medical devices.

European Union Medical Device Regulation (EU MDR)

The European Union Medical Device Regulation (EU MDR 2017/745) establishes the regulatory framework for the safety, performance, and market access of medical devices in the European Union (EU). Replacing the Medical Device Directive (MDD 93/42/EEC) and Active Implantable Medical Device Directive (AIMDD 90/385/EEC), the EU MDR introduces stricter requirements for risk classification, clinical evaluation, and PMS.

EU MDR enhances product quality and safety, product transparency, and regulatory oversight by strengthening risk classification, requiring comprehensive clinical evaluation and post-market clinical follow-up (PMCF). Furthermore, EU MDR implements Unique Device Identification (UDI) for traceability, mandating PMS and vigilance reporting.

EU MDR applies to medical device manufacturers placing products on the EU market. Additionally, EU MDR directs importers, distributors, and healthcare institutions using or modifying medical devices, software whose products function as medical devices, and Authorized Representatives (ARs) acting on behalf of non-EU manufacturers.

European Union In Vitro Diagnostic Medical Device Regulation (EU IVDR)

The European Union In Vitro Diagnostic Medical Device Regulation (EU IVDR 2017/746) establishes the regulatory framework for the safety, performance, and market access of in vitro diagnostic (IVD) medical devices in the EU. Replacing the In Vitro Diagnostic Medical Devices Directive (IVDD 98/79/EC), it introduces stricter requirements for classification, clinical evidence, and PMS.

EU IVDR enhances product safety and reliability by implementing a risk-based classification system (Class A, B, C, D), strengthening clinical performance evaluation, and requiring UDI for traceability. EU IVDR further mandates PMS and performance monitoring and increases notified body involvement in conformity assessments.

EU IVDR applies to manufacturers of in vitro diagnostic medical devices placing products on the EU market, importers and distributors, and healthcare institutions developing or modifying in-house IVDs. Moreover, EU IVDR applies to software developers providing digital solutions classified as IVD medical devices, and Authorized Representatives (ARs) acting on behalf of non-EU IVD manufacturers.

What Are the Core Processes of a Medical Device QMS?

The core processes of a medical device QMS are listed below.

• Document Control: Document control manages the creation, approval, distribution, revision, and retiring of QMS documents. The document control process ensures compliance, version control, and traceability.
• Change Management: Change managementcontrols the implementation of changes in design, processes, documentation, or other changes within the organization. Change management helps prevent unintended consequences of changes.
• Training Management: Training managementensures staff competency.Training management involves tracking and documenting employee training on QMS processes, regulatory requirements, and device-specific procedures to ensure competency.
• Nonconformance Management: Nonconformance management identifies, records, and resolves nonconforming materials, products, or processes. Nonconformance management involves issue investigation, CAPA, and continuous quality improvement within the QMS structure.
• Complaint Handling: Complaint handling is the management of complaints within a QMS.Complaint handling is a structured process for capturing, investigating, and resolving customer complaints.
• CAPA Management: CAPA management is a QMS-driven process focused on identifying, resolving, and preventing recorded issues. CAPA management isimplemented to identify root causes and apply CAPA on recorded issues such as product and process failures.
• Audit Management: Audit management is a systematic planning, execution, and review of audits and inspections to assess QMS compliance. Audit management facilitates internal and external audits to assess QMS compliance with applicable regulatory requirements.
• Supplier Management: Supplier management maintains a structured QMS framework for evaluating, selecting, and monitoring suppliers to minimize risks and ensure high-quality product sourcing. Supplier management integrates risk assessment during supplier audits to ensure suppliers meet customer and regulatory requirements.
• Equipment Management: Equipment management is a process of ensuring proper quality control for equipment. Equipment management involves proper registration, qualification, calibration, maintenance, and disposal of equipment used in manufacturing and quality control processes.
• Product Management: Product management oversees a product’s entire lifecycle, from concept and development to market introduction and ongoing support. Product management can also be handled in the product life cycle. This helps ensure compliance with risk management requirements (e.g., ISO 14971), usability specifications, and market requirements.
• Post-Market Surveillance (PMS): PMS refers to the processes and activities used to monitor the safety, performance, and quality of a product after market release.PMS conducts real-world performance monitoring, analyzing adverse events, safety trends, and user feedback to drive proactive risk mitigation, regulatory reporting, and product improvement within the QMS framework.

Document Control

Document control is the management of QMS-related documents and records. Document control ensures that relevant documentation, such as policies, procedures, work instructions, and specifications, are created, reviewed, approved, updated, and retired as necessary. 

Document control within a medical device QMS manages the creation, maintenance, and accessibility of essential documents and records. The document control process standardizes document drafting, reviewing, and approval, covering SOPs, WIs, and compliant records. Version control ensures access to only the latest approved documents, preventing outdated procedures.

Retention policies meet regulatory mandates, such as the EU MDR requirement to store records for at least 10 years after a device’s final market placement. Personnel training ensures familiarity with revised or critical documents, requiring acknowledgment of updates.

Document control supports audit readiness by keeping records accessible for internal audits, regulatory inspections, and Notified Body reviews, ensuring compliance with applicable requirements.

By establishing robust document control procedures, companies can mitigate the risk of errors, inconsistencies, and outdated information. Additionally, effective document management facilitates transparency, accountability, and traceability.

Change Management

Change management is a systematic QMS approach to implementing process modifications, product updates, and workflow improvements.

Change management within a medical device QMS controls modifications while ensuring compliance and product integrity. Change identification captures necessary modifications in design, manufacturing, labeling, suppliers, or QMS processes. Impact assessment evaluates regulatory compliance, product safety, product performance, and risk management (e.g. ISO 14971).

Approval processes require cross-functional and regulatory reviews before implementation. Implementation updates relevant documents, work instructions, and training records while ensuring personnel readiness. Verification confirms effectiveness through post-implementation reviews, preventing unintended risks. Regulatory compliance mandates report significant changes to bodies such as the FDA or Notified Bodies under EU MDR when required.

Change management ensures that any alterations made to the quality processes, documents, and products are carefully evaluated to minimize risks and maximize benefits. Change management is essential to a QMS as it enables companies to adapt to evolving customer and regulatory requirements while safeguarding quality and compliance.

Training Management

Training management is the process that ensures that training needs are met and the needed competencies are available to comply with relevant requirements.

Training management within a medical device QMS ensures personnel understand process modifications and regulatory updates. Communication informs employees who are affected by new procedures, process changes, or regulatory requirements. Role-based training sessions, tailored to responsibilities and interactions with the change, are another component of effective training management.

Competency assessments verify understanding through quizzes, tests, or practical demonstrations. Training records are maintained such as logs, certificates, and compliance reports. Documented training supports audit readiness for internal and external audits.

By providing comprehensive training programs, companies ensure employees are competent to do their jobs and understand their roles, responsibilities, and requirements of a QMS. Effective training management helps minimize errors and improve productivity.

Nonconformance Management

Nonconformance management is the systematic process of identifying, documenting, investigating, resolving, and preventing deviations or nonconformances related to procedures, products, suppliers, and more.

The nonconformance management within a medical device QMS involves investigation using methodologies such as 5 Whys and Fishbone Diagrams (Ishikawa.) Implementing CAPA procedures is essential to prevent the recurrence of recorded issues. Regulatory compliance on nonconformance management involves reporting obligations such as 21 CFR 820 and EU MDR vigilance reporting. Logging cases in issue logs and maintaining records are essential during internal and external audits.

Nonconformance management ensures product quality, safety, and regulatory compliance. When nonconformities occur, addressing them promptly and effectively is essential to prevent recurrence, minimize the impact on product quality and safety, and ensure continuous improvements.

Complaint Handling

Complaint handling is a formal QMS process for receiving, documenting, investigating, and resolving customer complaints to improve product quality and compliance.

Medical device complaint handling captures complaints from customers, healthcare professionals, or regulatory bodies in a structured system. Investigation determines whether issues stem from design, manufacturing, labeling, or user error, often using CAPA and risk-based evaluations.

Regulatory reporting ensures timely submission of serious complaints such as Medical Device Reports (MDRs) to the FDA, Vigilance Reports in the EU, and Field Safety Corrective Actions (FSCA) when required. CAPA implementation addresses recurring complaints and prevents similar issues.

Data analysis monitors complaint trends to identify systemic quality concerns and improve product performance. Additionally, complaint resolution involves corrective actions and customer notification of findings, if necessary.

Complaint management enables companies to respond effectively to customer feedback, address quality issues, and drive continuous improvement. By prioritizing customer satisfaction and actively engaging with customer complaints, companies can build trust, loyalty, and long-term relationships with their customers while maintaining compliance with regulatory requirements.

CAPA Management

CAPA management is a QMS process designed to identify, resolve, and prevent recorded issues from recurrence or avoid issue occurrence.

CAPA management within the medical device industry ensures a structured approach to identifying, investigating, and resolving recorded issues. Issue identification detects problems such as customer complaints, audit findings, or production issues requiring CAPA. Root cause analysis applies methods such as 5 Whys and Fishbone Diagrams (Ishikawa). Corrective actions eliminate root causes to prevent recurrence.

Preventive actions establish proactive process improvements, training, and risk mitigation strategies to avoid issue occurrence. Effectiveness checks verify that implemented actions resolve issues effectively and without introducing new risks. Documentation maintains CAPA records, audit trails, and regulatory submissions to ensure compliance during inspections.

Effective CAPA management helps companies minimize risks, improve processes, and ensure continuous improvement.

Audit Management

Audit management is a QMS process that ensures internal and external audits are effectively planned, executed, and reviewed.

Medical device audit management involves audit planning, which establishes a periodic program covering internal, supplier, and external regulatory audits based on risk and compliance needs. Audit execution assesses adherence to documented procedures, regulations, and quality objectives.

Audit findings are categorized into conformities, nonconformities (NCs), observations, and suggestions for improvement (SFI), or opportunities for improvement (OFI). Audit documentation maintains reports, checklists, and follow-up records for regulatory inspections and internal reviews.

Audit management ensures that quality management processes are effectively implemented and followed across the company. Audit management assesses compliance with internal policies, procedures, and applicable requirements.

Supplier Management

Supplier management is a QMS process that ensures suppliers meet quality and compliance requirements.

Medical device supplier management involves evaluating, selecting, and monitoring suppliers to ensure that they consistently deliver uniform and high-quality products or services. Supplier qualification evaluates and approves suppliers based on quality, reliability, and compliance. Supplier audits assess adherence to customers and regulatory requirements.

Furthermore, supplier agreements define responsibilities, specifications, and compliance expectations. Performance monitoring reviews delivery times, defect rates, and compliance records to maintain consistent quality. Nonconformance management applies CAPA to address supplier-related issues. The medical device QMS includes Approved Supplier List (ASL) maintenance to ensure operational consistency for future company needs and orders.

Effective supplier management helps companies identify reliable and capable suppliers, optimize supply chain performance, and mitigate risks associated with poor supplier performance.

Equipment Management

Equipment management is a systematic approach to ensuring the ongoing functionality, accuracy, and reliability of all equipment used within the companies’ processes.

Equipment management within a medical device QMS involves the selection, qualification, calibration, maintenance, and disposal of equipment used to manufacture medical devices. Equipment selection and qualification ensure compliance with manufacturing, inspection, and testing requirements. Calibration and maintenance programs prevent performance deviations.

QMS documentation requires maintaining calibration records, maintenance logs, and service reports for audit readiness. Nonconformance management addresses equipment-related issues, triggering CAPA when necessary. Personnel training ensures operators handle, maintain, and troubleshoot equipment correctly.

Properly managed equipment ensures that manufacturing processes are conducted accurately and consistently, minimizing the risk of defects or deviations from quality specifications.

Product Management

Product management within a medical device QMS is a structured approach to overseeing a medical device’s design, development, production, regulatory compliance, and lifecycle management.

Key elements of the product management process include design controls, risk management, and record controls related to different stages of the product life cycle. PMS that monitors product performance, complaints, and adverse events to drive improvements is another key element for product management.

Product management ensures that devices meet safety, performance, and regulatory requirements throughout the medical device lifecycle.

Post-Market Surveillance

PMS operates within a medical device QMS to monitor, collect, and analyze data on medical devices after market release. PMS ensures compliance with safety, performance, and regulatory requirements throughout a device’s lifecycle. Regulatory mandates for PMS include EU MDR (2017/745), EU IVDR (2017/746), FDA 21 CFR Part 820, and ISO 13485:2016.

Medical device post-market surveillance involves data collection, risk assessment, regulatory reporting, clinical follow-ups, corrective actions, and periodic updates. Real-world performance data originates from customer complaints, adverse event reports, clinical studies, and literature reviews.

Trend analysis identifies safety or performance risks, aligning with ISO 14971. Regulatory obligations require submitting vigilance reports to portals of FDA, EU, and WHO, if necessary.

Post-market Clinical Follow-up (PMCF) confirms safety and effectiveness through ongoing clinical evaluations. CAPA addresses post-market findings, and necessary reporting is done to regulatory bodies.

PMS in medical device QMS ensures compliance with EU MDR, IVDR, US FDA 21 CFR Part 820, and ISO 13485 requirements. PMS enables continuous monitoring which helps identify adverse events, safety issues, recalls, unexpected risks, and other problems as they arise. Risk management refines assessments and drives preventive actions. Performance evaluations identify trends and enable design improvements. Market confidence strengthens through transparency, regulatory oversight, and commitment to safety.

How to Best Establish and Implement a Medical Device QMS?

The steps to consider when establishing and implementing a medical device QMS are listed below.

1. Understand Regulatory and Standard QMS Requirements: Identify relevant requirements such as ISO 13485, FDA QSR, MDR, and IVDR, based on target markets, device classification, and product scope. Afterward, review regulatory guidance documents and applicable requirements.
2. Define Quality Objectives and Policies: Draft a quality policy demonstrating a commitment to regulatory compliance and product safety. Establish SMART (Specific, Measurable, Achievable, Relevant, Time-bound) quality objectives.
3. Define the Scope of the QMS: Identify the products, processes, and departments covered under the QMS. Define the product lifecycle stages included (design, manufacturing, post-market activities).
4. Develop a Quality Manual: Outline the scope, organizational roles, regulatory references, and process interactions. For instance, ensure alignment with ISO 13485:2016 Clause 4.2.2 and applicable regulatory requirements.
5. Implement a Medical Device QMS Software: Choose an electronic Quality Management System (eQMS) to digitize medical device QMS processes while other companies choose to implement eQMS after the whole QMS is set up. Ensure the system supports document control, design control, CAPA, audit management, training records, and more.
6. Implement Document and Record Control: Define a document approval process with version control and change management. Maintain compliance with record retention policies (e.g., FDA requires 10 years for certain records).
7. Establish Policies, Procedures, and Work Instructions: Develop policies (e.g., company and quality policies), SOPs for processes, and work instructions for step-by-step task execution from processes.
8. Train Employees on QMS and Regulatory Compliance: Conduct role-specific QMS training for employees. Maintain training records and provide refresher courses on processes such as risk management, design controls, and regulatory updates.
9. Implement Risk Management Processes: Conduct risk assessments using Failure Mode and Effects Analysis (FMEA) and Hazard Analysis. Maintain a Risk Management File (RMF) with risk evaluation and mitigation measures.
10. Establish Supplier and Vendor Controls: Qualify and monitor suppliers in compliance with applicable requirements. Implement a supplier approval program with risk-based evaluation and conduct periodic supplier audits while maintaining an Approved Supplier List (ASL).
11. Conduct Internal Audits and Management Reviews: Develop an internal audit program to assess QMS effectiveness and prepare for future regulatory inspections. Conduct annual management reviews to evaluate QMS performance and identify improvements.
12. Implement CAPA: Establish a CAPA system to investigate and prevent recorded issues. Utilize root cause analysis tools such as 5 Whys, Fishbone Diagram, or Fault Tree Analysis.
13. Set Up Post-Market Surveillance (PMS) and Vigilance System: Define PMS procedures per applicable requirements such as EU MDR (2017/745) Articles 83-86. Implement processes for Medical Device Reporting (MDR), Field Safety Corrective Action (FSCA) process, post-market clinical follow-up, and customer complaint handling.
14. Continuously Improve the QMS: Monitor key performance indicators (KPIs) for QMS effectiveness. Implement continuous improvement initiatives (e.g., Lean, Six Sigma) and encourage a culture of continuous improvement through employee feedback and CAPA trends.

How Does a Medical Device QMS Differ from a Pharmaceutical QMS?

The main difference between a medical device QMS and a pharmaceutical QMS is the regulatory requirements, life cycle processes, regulatory reporting, and terminology differences.

Key differences between medical device QMS and pharmaceutical QMS are listed below.

• Regulatory Requirements: QMS in a medical devices company may follow ISO 13485, FDA 21 CFR Part 820 (QSR), EU MDR (2017/745), or EU IVDR (2017/746). These requirements emphasize design controls, risk management, usability engineering, and lifecycle monitoring. Pharmaceutical QMS adhere to requirements such as Good Manufacturing Practices (GMP) under FDA 21 CFR Parts 210 & 211, EU GMP, ICH Q10 (Pharmaceutical QMS). The focus is on drug formulation, sterility assurance, batch-to-batch consistency, and pharmacovigilance.
• QMS Processes and Lifecycle Differences: Medical device QMS prioritizes design controls, validation studies, and post-market surveillance (PMS) to track device safety and performance in real-world use. Pharmaceutical QMS focuses on drug formulation, stability studies, sterility assurance, and batch release verification to ensure product consistency.
• Regulatory Reporting: Medical device manufacturers must report device-related incidents, malfunctions, and adverse events through Medical Device Reporting (MDR) in the US and EU Vigilance Reporting in MDR/IVDR. Pharmaceutical companies report adverse drug reactions (ADRs), medication errors, and long-term safety data in the FDA’s MedWatch program and the EudraVigilance system in the EU. The reporting for medical devices is termed vigilance reporting, while for pharmaceutical, it is termed pharmacovigilance reporting.
• Terminology Differences: Medical Device QMS uses terms like DHF, DMR or Technical File, DHR, and Unique Device Identification (UDI). Pharmaceutical QMS includes batch records, certificates of analysis (CoA), and stability studies.

What Is the Role of Quality Management Software for Medical Device Companies?

The role of quality management software for medical device companies is to help ensure regulatory compliance, process efficiency, and risk mitigation of medical devices. An electronic Quality Management System (eQMS) streamlines quality management processes and helps ensure compliance with ISO 13485, FDA 21 CFR Part 820 (QSR), and EU MDR/IVDR requirements.

Medical device QMS software centralizes document control, automates CAPA management, streamlines supplier audits, and tracks training compliance. Integrated risk management supports failure mode analysis (FMEA) and complaint handling, while post-market surveillance streamlines adverse event reporting and vigilance compliance.

Medical device companies that manage records electronically must ensure their electronic systems, such as an eQMS, comply with FDA 21 CFR Part 11 and EU Annex 11 (if applicable). Additionally, FDA 21 CFR Part 820 and ISO 13485 require these systems to be validated to ensure accuracy, reliability, and compliance.

SimplerQMS provides fully validated QMS software for medical device companies that meets the software validation requirements of ISO 13485 and FDA 21 CFR Part 820 and is validated according to GAMP5. SimplerQMS complies with FDA 21 CFR Part 11 and EU Annex 11 requirements for the use of electronic records, electronic signatures, and computerized systems in regulated environments.

SimplerQMS helps medical device companies ensure compliance with applicable QMS requirements, including ISO 13485, FDA 21 CFR Part 820, EU MDR, and EU IVDR. The system offers comprehensive QMS process support, including document control, change control, design control, training, CAPA, audits, supplier management, vigilance reporting, and more.