Medical Device Document Control: Definition, Process, and Requirements

Medical device document control is a process of controlling the documentation specific to the medical device industry. Document control is an organized process designed for reviewing, approving, tracking, submitting, versioning, retiring, and archiving documents and records.

The systematic process of document control is important to the medical device industry’s ability to manage product development processes effectively, maintain quality, and ensure compliance. Moreover, document control is an integral part of the quality management system (QMS).

Medical device companies handle several types of documents and records. To mention a few documents that are common in this industry are quality manuals, design history files (DHF), and technical files. Meanwhile, records can include device master records (DMR), device history records (DHR), and training records, among others.

Core procedures and processes involved in document control typically involve document creation and identification, review and approval, secure storage and retrieval, as well as the controlled retirement of outdated materials. These processes are governed by various standards and regulations, such as ISO 13485:2016, EU MDR, FDA 21 CFR Part 820, and FDA 21 CFR Part 11, which ensure proper documentation practices.

To streamline compliance and improve efficiency, medical device companies often use document management systems with robust document control capabilities, which can be paper-based, electronic, or hybrid.

What Is Medical Device Document Control?

Document control is the process of controlling documents and records throughout their lifecycle. Medical device document control refers to the specific process of controlling documents and records in the medical device industry.

Document control ensures that documents are accessible to authorized personnel and that only the most current versions are available for use within the organization. Companies in the medical devices sector must adhere to requirements related to document control.

While document control and document management are interconnected, they are distinct aspects of document handling within an organization. Document control is a component of the broader document management process.

What Is the Medical Device Document Control Process?

The medical device document control process involves a set of steps for controlling documents through their lifecycle.

The key seven steps in the document control process are listed below.

1. Document Identification: Assign a unique identifier or ID to each document to facilitate tracking and version control.
2. Document Review: Route the document for review to designated personnel with relevant expertise.
3. Document Approval: Submit the document for approval by relevant employees. The approval process includes recording details of information such as the approval date and approver credentials.
4. Document Tracking: Monitor document changes, versions, and access to ensure that only the most up-to-date versions are in use, preventing the use of outdated information from being used.
5. Change Control Process: Any document modification must follow a structured change control process. Changes are reviewed, approved, and documented to ensure that any changes made to a system, process, or product are appropriately assessed, recorded, and managed.
6. Medical Device Record Retention and Archiving: Securely store and retain documents for the required period as specified by requirements, ensuring they are accessible for audits or inspections.
7. Document Retirement: Remove outdated documents from active use of the medical device organization by marking them as retired.

What Is the Difference Between Document Control and Document Management?

The primary distinction between document management and control is seen in their respective fields of emphasis.

Document control focuses on reviewing, approving, tracking, and controlling versions of documents. It ensures that only the most recent, approved versions are available for use while archiving previous versions to maintain historical records.

Document management focuses on the storage, organization, retrieval, and distribution of documents and records throughout the company. It enables users to easily find, share, and create new documents as needed.

While document control is a critical part of document management, not every managed document is controlled. Document control specifically applies to documents that must meet regulatory requirements, while document management encompasses all documents within the organization.

The differences between document control and document management are illustrated in the image below.

What Is the Importance of Documentation in the Medical Device Industry?

Documentation is critical in the medical device industry for ensuring product safety, quality, and compliance with applicable regulations, standards, and guidelines.

Accurate and comprehensive documentation provides a record of processes, procedures, and data, ensuring traceability and reproducibility throughout the product lifecycle. This is vital for demonstrating compliance with international standards such as ISO 13485:2016 and regulations such as FDA 21 CFR Part 820 and Regulation (EU) 2017/745 (EU MDR), among others.

Medical device documentation plays a key role in the Quality Management System. This process helps in identifying nonconformances, enabling timely corrective and preventive actions (CAPA). Additionally, well-maintained documentation also facilitates audits and inspections, providing a well-organized record of all processes and making it easier to verify compliance.

Moreover, proper documentation helps safeguard data integrity, supports effective knowledge transfer, and drives continuous improvement, ensuring that devices are consistently safe and meet customer and regulatory requirements.

What Are the Types of Documents in the Medical Device Industry?

In the medical device industry, documents serve as controlled references that outline processes, methods, and requirements before tasks are carried out. These documents provide guidelines that can be updated as processes evolve, ensuring organizations maintain accurate and current quality standards. Documentation is essential for meeting customer and regulatory requirements and ensuring the safety, quality, and compliance of medical devices.

Examples of documents used in the medical device industry are listed below.

• Quality Manual
• Design History File (DHF)
• Post Market Surveillance (PMS) Plan
• Standard Operating Procedures (SOPs)
• Work Instructions (Wis)
• Technical Files
• Risk Management Plans
• Supplier Qualification
• Labeling and Packaging Documents
• Equipment Manuals
• Safety Data Sheets (SDS)

From design to post-market operations, documentation is essential to support the lifecycle of medical devices while guaranteeing adherence to global standards and laws.

Quality Manual

The Quality Manual defines the primary Quality Management System (QMS) framework. This document outlines policies and objectives that uphold conformity to standards and requirements. Its purpose is to provide a reference for employees and auditors as a starting point to learn about the quality management of a medical device company.

Design History File (DHF)

The Design History File (DHF) documents the complete design development process of a medical device. This document ensures adherence to the approved design plan. Its purpose is to demonstrate that the design followed proper procedures, supporting both regulatory submissions and inspections.

The Design History File (DHF) is essential for cases such as FDA reviews or quality certifications. For example, when creating a new medical device, the DHF shows all the steps taken, like design plans, safety checks, and testing, to prove the device is safe, effective, and meets the device’s specifications and requirements.

Post Market Surveillance (PMS) Plan

The Post Market Surveillance (PMS) plan defines the strategy and methodology the manufacturer will implement to gather and evaluate data on the medical device’s performance after it enters the market. The PMS plan outlines the data sources, review frequency, and responsibilities of assigned personnel.

Standard Operating Procedures (SOPs)

Standard Operating Procedures (SOPs) outline routine methods to ensure consistency and regulatory compliance throughout the medical device manufacturing process. SOPs are designed to standardize practices, minimize errors, and act as a crucial resource for staff training and ensuring regulatory compliance.

Work Instructions (WIs)

Work instructions provide step-by-step directives for specific tasks. These documents are born from SOPs that need further directions. Work Instructions help employees perform duties consistently and uniformly, especially for complex or critical tasks.

Technical Files

In the EU setting, technical files compile all crucial documentation related to a device’s design, manufacturing, and testing phases. Their primary purpose is to verify that the device meets all safety, performance, and regulatory requirements. Technical files also serve as key evidence during market approval processes for CE marking under the EU MDR (2017/745) and are essential for demonstrating compliance during audits. Although the technical file and the Device Master Record (DMR) as defined by the U.S. FDA differ in terminology and scope, they are interconnected through shared documentation, traceability, and continuous updates stemming from the device’s design, production, and post-market feedback.

Risk Management Plans

A risk management plan is a comprehensive document that describes the steps involved in finding, assessing, controlling, and monitoring hazards during a medical device’s lifecycle. It outlines the procedures, responsibilities, and strategies for managing risks that adhere to requirements and regulations. This documented plan ensures that medical devices are developed with a focus on quality and safety.

Supplier Qualification

Supplier qualification documentation outlines the qualifications and approvals of suppliers to ensure compliance with relevant requirements. The purpose of these documents is to ensure the consistency and reliability of sourced materials or components, aiding in both initial supplier selection and ongoing performance monitoring.

Labeling and Packaging Documents

Labeling and packaging documents confirm that devices are labeled and packaged in compliance with current and applicable regulations. The purpose of these documents is to prevent errors, ensure user safety, and fulfill all labeling and packaging requirements.

Equipment Manuals

Equipment manuals are clear instructions for operating and maintaining production and testing the medical device. These documents aim to ensure safe and effective equipment use, prolong operational life, and facilitate efficient troubleshooting by trained personnel.

Safety Data Sheets (SDS)

Safety Data Sheets (SDS) previously known as material safety data sheets (MSDS) for a medical device contain vital information on the safe handling, storage, and disposal of materials related to the product. The documents identify potential hazards, outline protective measures, and provide first-aid instructions for exposure to harmful materials such as chemicals. SDS helps employees and emergency responders manage materials safely, reducing accident risks and ensuring compliance with regulations.

What Are the Types of Records in the Medical Device Industry?

Records refer to documented evidence of activities, decisions, or outcomes related to the design, manufacturing, testing, and regulatory compliance of a medical device. In the medical device industry, records play a vital role and are created to ensure traceability, accountability, and compliance with customer and regulatory requirements.

The medical device records provide essential proof during audits and inspections, demonstrate compliance with regulatory requirements, and ensure the quality and safety of medical devices throughout their lifecycle. They are integral to maintaining transparency and supporting quality management systems (QMS).

Examples of records used in the medical device industry are listed below.

• Device Master Record (DMR)
• Device History Record (DHR)
• Design Review Records
• Post-Market Surveillance Data
• Management Review Minutes of Meeting (MOM)
• Equipment Calibration Records
• Equipment Maintenance Logs
• Nonconformance Records
• Complaint Records
• Corrective and Preventive Action (CAPA) Records
• Audit Reports
• Training Records
• Environmental Monitoring Records

Device Master Record (DMR)

A Device Master Record (DMR) is a compilation of all the instructions, drawings, documents, and specifications necessary to manufacture a finished medical device. The purpose of the DMR is to serve as a comprehensive reference to ensure consistent manufacturing in line with approved design specifications and quality standards. The DMR helps guide production personnel, manage manufacturing processes, and support quality inspections to confirm each device meets the established design criteria. While the term “Device Master Record” is specific to U.S. FDA regulations, the European Union’s regulatory framework requires “technical documentation” or a “technical file,” which is often broader in scope. These technical files not only cover manufacturing details but also encompass a wider range of documentation to ensure compliance with EU medical device requirements and adherence to both regulatory and customer standards.

Device History Record (DHR)

A Device History Record (DHR) documents the complete history of each device or batch produced, including details on production, testing, inspection, and packaging. The purpose of the DHR is to ensure traceability and verify compliance with the Device Master Record, ensuring each device meets regulatory and quality standards. The DHR is used in audits and inspections to confirm that devices are manufactured according to approved processes and specifications.

Design Review Records

Design Review Records are the histories of the evaluations, assessments, and decisions made during formal reviews of the device design process. The main purpose of these records is to ensure that the design is thoroughly evaluated at critical stages, confirming that requirements are met, risks are addressed, and changes are justified. These records are used to support regulatory submissions, internal audits, and design validations, providing evidence that due diligence was followed throughout the design lifecycle.

Post-Market Surveillance Data

Post-market surveillance data are raw records collected during the surveillance process which include complaints, adverse event reports, customer feedback, service/maintenance reports, and device performance data. These PMS records are analyzed to produce outcomes such as risk assessments, trend analyses, and corrective and preventive actions (CAPA).

Management Review Minutes of Meeting (MOM)

Management review minutes are classified as records because they capture the outcomes of the review process. They serve as evidence of the discussions, decisions, and actions taken during a management review meeting.

Equipment Calibration Records

Equipment Calibration Records are records of calibration intervals, results, and standards used to verify that production and test equipment operate within specified tolerances.

It ensures equipment accuracy and reliability, confirming that measurements and outputs remain consistent and dependable. Calibration records are useful in quality investigations, helping determine if equipment performance contributed to deviations and supporting corrective actions.

Equipment Maintenance Logs

Equipment maintenance logs track routine servicing, repairs, and scheduled upkeep performed on manufacturing and testing equipment. The logs help ensure equipment operates properly, minimizing downtime, preventing quality issues, and extending equipment lifespan. Maintenance logs are reviewed during audits or quality investigations to confirm that machinery has been properly maintained, reducing the likelihood of process failures.

Nonconformance Records

Nonconformances (NCs) are records of instances where products, processes, or procedures fail to meet established specifications or requirements. These records enable systematic identification, evaluation, and control of nonconformities, prompting corrective actions to prevent recurrence.
During audits or investigations, records demonstrate how deviations were managed. Management of nonconformance records shows the organization’s commitment to continuous improvement.

Complaint Records

Complaint records capture customer or user feedback regarding device quality, durability, or performance issues. The information in the complaint records helps the company address product issues, enhance design, ensure regulatory compliance, and inform post-market surveillance. These records enable data generation for complaint analysis and assigning corrective and preventive actions for the affected area of the organization.

Corrective and Preventive Action (CAPA) Records

Corrective and Preventive Action known as CAPA are records of investigation, actions taken, and effectiveness verification of identified issues. Records related to CAPA help ensure that root causes of problems are understood, and proper measures are taken to prevent recurrence or occurrence. Auditors and regulators review CAPA records to confirm that the company actively improves its quality system by addressing both current issues and potential future risks.

Audit Reports

Audit reports are summarized findings, observations, and conclusions from internal or external audits of the quality management system (QMS) and related processes. These reports provide evidence of ongoing compliance monitoring, identify areas for improvement, and verify the effectiveness of the QMS. Audit reports are further evaluated during management reviews to track corrective actions, allocate resources for improvements, and maintain regulatory compliance.

Training Records

Training records compile the completion, scope, and effectiveness of personnel training programs on procedures, regulations, and equipment use. These records confirm that employees possess the necessary knowledge and skills for their assigned tasks. Training records are vital during audits or investigations to check the root cause of nonconformance.

Environmental Monitoring Records

Environmental monitoring records capture data on environmental conditions (e.g., temperature, humidity, particulate levels) in controlled manufacturing or storage areas for a medical device. These records ensure that environmental parameters remain within specified limits to maintain product quality and device stability. These monitoring logs help determine if environmental factors contributed to deviations in cases of product quality issues.

What Is the Difference Between Documents and Records in the Medical Device Industry?

Documents are controlled references that outline processes, methods, and requirements before performing activities. They provide guidance on how tasks should be carried out and are regularly updated and revised.

Records are evidence that activities were performed as prescribed. They capture the results of actions taken, are generally not modified once created, and serve as proof of compliance and performance validation.

Documents and records are both essential to the medical device industry because they help guarantee that quality, compliance, and requirements are fulfilled at every stage of the product lifecycle.

Which Standards and Regulations Specify Requirements for Medical Device Documentation?

Requirements for medical device documentation are specified by standards and regulations such as ISO 13485:2016, Regulation (EU) 2017/745 (EU MDR), FDA 21 CFR Part 820, and FDA 21 CFR Part 11.

ISO 13485:2016

ISO 13485 defines the requirements for a quality management system tailored to the medical device industry. ISO 13485 emphasizes controlling documentation, including procedures, records, and quality manuals, to ensure consistent product quality and regulatory compliance.

Section 4.2.4 (Control of Documentation) of ISO 13485:2016 specifically states that:

“Documents required by the quality management system shall be controlled.”

Section 4.2.4 addresses the control of documents within a quality management system. It requires organizations to establish procedures for document approval, review, update, and distribution. The section ensures that only current and approved documents are available for use, preventing the use of obsolete or unauthorized documents. It mandates that documents are legible, identifiable, and retrievable, maintaining their integrity and accessibility.

Section 4.2.5 of ISO 13485:2016 focuses on the control of records, which serves as evidence of conformity to requirements and the effective operation of the quality management system. It requires organizations to establish procedures for record identification, storage, protection, retrieval, retention, and disposal. The section ensures that records remain legible, readily identifiable, and retrievable, preserving their integrity and confidentiality throughout the retention period.

Under this section, it specifically states the following:

“Records shall be maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system.

The organization shall document procedures to define the controls needed for the identification, storage, security and integrity, retrieval, retention time and disposition of records.

Records shall remain legible, readily identifiable and retrievable. Changes to a record shall remain identifiable.

The organization shall retail the records at least the lifetime of the medical device as defined by the organization, or as specified by applicable regulatory requirements, but not less than two years from the medical device release by the organization”.

Regulation (EU) 2017/745 (EU MDR)

Regulation (EU) 2017/745, known as the EU Medical Device Regulation (MDR), provides a detailed framework for the documentation and control of medical devices within the European Union. The EU MDR highlights the importance of accurate, up-to-date documentation to ensure device safety and regulatory compliance.

The EU MDR requires manufacturers to establish and maintain robust document control processes as part of their quality management system. Technical documentation must demonstrate conformity with the regulation, be well-organized, and be readily accessible to competent authorities when needed. This documentation spans the entire device lifecycle, including design, manufacturing, clinical evaluation, and post-market surveillance.

In Regulation (EU) 2017/745 (EU MDR), document control is not addressed under a single dedicated section but is integrated throughout the regulation in various articles and annexes. Key references include the following.

• Annex II (Technical Documentation) outlines the necessary content for technical documentation. It emphasizes the importance of maintaining comprehensive, current, and well-organized records to demonstrate compliance with MDR requirements. Effective document control ensures the accuracy and accessibility of technical documentation.
• Annex III (Technical Documentation on Post-Market Surveillance) details the required post-market surveillance plan and related documentation. Manufacturers are responsible for managing and maintaining these records to ensure continued compliance and traceability.
• Article 10 (General Obligations of Manufacturers) mandates that manufacturers establish, document, and maintain a quality management system (QMS). It further provides guidelines for the retention of records. It mentions that manufacturers must retain technical documentation, the EU declaration of conformity, and any relevant certificates, along with updates, for at least 10 years after the last device covered is placed on the market. For implanted devices, the retention period extends to a minimum of 15 years. Effective document control is integral to the QMS, ensuring procedures, records, and reports are managed and retained accordingly.
• Annex IX (Conformity Assessment Based on a Quality Management System and Assessment of Technical Documentation) entails manufacturers maintaining controlled documentation as part of the QMS for assessments conducted by notified bodies.
• Article 83 and Article 84 (Post-Market Surveillance System and Plan) highlight the importance of documenting post-market surveillance activities to monitor device performance and safety, supported by controlled documentation.
• Article 8 (Use of Harmonized Standards and Common Specifications) urges the use of harmonized standards, such as ISO 13485, which includes explicit requirements for document control within the QMS framework.

FDA 21 CFR Part 820

FDA 21 CFR Part 820, referred to as the Quality System Regulation (QSR), sets forth the requirements and specifications for the methods, facilities, and controls involved in the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for human use. 21 CFR Part 820 requirements ensure that devices are safe, effective, and comply with the Federal Food, Drug, and Cosmetic Act.

Key sections of FDA 21 CFR Part 820 for Document and Record Control is 820.40 Document Controls. Requires the establishment and maintenance of procedures to control all quality system documents, including their approval, distribution, and modification. This section requires manufacturers to establish procedures for managing quality system documents. It covers approval, distribution, and change control.

The documents must be reviewed and approved by authorized personnel, with records of names, signatures, and dates. For distribution, current, approved versions must be available at relevant locations. Change Control entails that modifications must be reviewed, approved, and distributed systematically, with records of previous versions maintained for traceability.

The aim is to ensure consistent, accurate, and compliant documentation, minimizing errors and supporting regulatory adherence.

FDA 21 CFR Part 11

FDA 21 CFR Part 11 places the criteria for electronic records and signatures to be deemed trustworthy, reliable, and equivalent to paper-based records and handwritten signatures. It applies to electronic records created, modified, maintained, archived, retrieved, or transmitted in compliance with FDA regulations.

Key sections in FDA 21 CFR Part 11 for document control are the following.

• 21 CFR 11.10(k): Addresses the control of electronic records and signatures in “closed systems.” The regulation mandates that organizations implement measures to prevent unauthorized access to electronic records. This includes ensuring that unauthorized personnel cannot modify, delete, or improperly access the records. It also requires that systems be sufficiently secure to protect against tampering or alterations that could compromise the authenticity of the electronic records.
• 11.30 Controls for Open Systems: Specifies additional controls for systems open to external access to safeguard data integrity and confidentiality. These controls are designed to minimize the risk of data breaches or unauthorized access, ensuring that the information remains reliable and secure when accessed remotely or across networks.
• 11.50 Signature Manifestations: Require that electronic signatures include the signer’s name, date, time, and the purpose of the signature. This requirement ensures that each action is clearly documented and can be traced back to the individual who performed it, providing a clear audit trail for verification purposes.
• 11.70 Signature/Record Linking: Electronic signatures are directly linked to a specific record it is associated with to prevent falsification or tampering. The integrity and authenticity of both the signature and the data it represents are preserved by making sure that signatures are inextricably linked to records.
• 11.100 General Requirements: Provides the basic requirements for electronic signatures, such as unique identifiers and secure password systems. By doing this, security and authenticity are guaranteed as each signature is linked to a particular person and is difficult for unauthorized parties to copy or change.
• 11.200 Electronic Signature Components and Controls: Technical components and controls needed to guarantee the authenticity and integrity of electronic signatures. It involves making certain that the technologies used to generate electronic signatures are secure, accurate, and tamper-proof.
• 11.300 Controls for Identification Codes/Passwords: Strict management of identification codes and passwords to prevent unauthorized access. Strict protocols must be put in place by organizations to issue, manage, and revoke passwords and identification codes to stop unwanted access.

The sections provide a thorough framework for guaranteeing security, reliability, and regulatory compliance with electronic documents and signatures. These offer precise instructions on how to preserve data integrity, guarantee correct documentation, and keep an efficient audit trail—all of which are critical for both regulatory compliance and preserving the credibility of electronic systems.

How Do Medical Device Document Management Systems Work?

A medical device Document Management System (DMS) is designed to handle the creation, review, approval, storage, retrieval, and archiving of all documents related to medical device development, manufacturing, quality assurance, and regulatory compliance.

A DMS can be paper-based, electronic, or a hybrid solution combining both methods. Although most commonly when people refer to a DMS, they mean an electronic DMS system.

Such electronic systems integrate document management and control functionalities to ensure that documents and records are securely stored, properly versioned, and easily accessible to authorized personnel. This structured approach ensures compliance with standards like ISO 13485, EU MDR, and FDA regulations.

Seven key steps typically involved in the workflow of a DMS are listed below.

1. Document Creation and Upload: Documents are either created within the system or uploaded, initiating the document management process.
2. Version Control: The DMS assigns version numbers and maintains histories of previous versions, ensuring only the most current, approved version is accessible.
3. Access Control: Permissions and user roles regulate access, ensuring that only authorized personnel can view, edit, or approve specific documents.
4. Document Review and Approval: Predefined workflows guide documents through necessary review and approval stages to verify accuracy, compliance, and relevance.
5. Time-Stamped Audit Trails: Every action—creation, modification, approval—is recorded with a timestamp, preserving a clear audit trail for inspections and audits.
6. Document Storage: Approved documents are securely stored in a well-structured repository, making them easy to locate and retrieve.
7. Retention and Archiving: Documents are retained according to regulatory requirements and securely archived after their active use period, ensuring long-term compliance and traceability.

What is the Role of Medical Devices Document Management Software?

Medical device document management software, including document control functionalities, plays a critical role in organizing, tracking, and managing all relevant documentation throughout a device’s lifecycle. By ensuring compliance with regulatory requirements and keeping documents current, properly organized, and easily accessible, medical device document management software helps streamline daily operations and improve overall efficiency.

These document management solutions typically offer automated version control, approval workflows, secure access, and audit trails. Such features protect document integrity, prevent unauthorized access, and ensure that only the most up-to-date, approved documents are used. Enhanced collaboration and communication capabilities also support more efficient decision-making within teams.

Document control is a vital component of a Quality Management System (QMS). SimplerQMS provides a robust QMS platform equipped with strong document management and control features, as well as functionalities like change control, training management, CAPA management, and audit management. Its built-in workflows guide users through each step, simplifying complex processes and maintaining regulatory compliance.

In addition to document management, SimplerQMS streamlines many other quality management processes such as training management, nonconformance handling, and corrective and preventive actions (CAPA), among others. These integrated QMS modules help organizations meet stringent regulatory requirements, including FDA 21 CFR Part 820, ISO 13485:2016, EU MDR, FDA 21 CFR Part 11, and others, while optimizing their internal processes.