What is traceability in design and development?
Traceability is the ability to systematically track and link every aspect of the development process, from initial requirements through design, testing, production, and post-market activities.
Traceability ensures that all elements of the device’s lifecycle are connected. This process ensures that every design component and change can be traced back to its source.
How is traceability used in medical device development?
Traceability is used throughout the medical device development lifecycle, with different purposes at each stage.
Requirements Traceability: Product requirements should be traceable throughout development. For example, each user requirement should be traceable to specific design inputs, design outputs, and eventually to verification and validation activities. Every design input (such as user needs or regulatory requirements) must have corresponding design outputs (such as technical specifications). Verification activities ensure that each design output meets the specified design input. Traceability also connects validation activities to user requirements, proving that the device performs as expected in real-world conditions. Traceability should work both ways. Developers need to be able to trace specific design elements back to their originating requirements. This helps developers, company leaders, and regulatory bodies understand the rationale behind specific design choices and gives confidence that all requirements have been addressed.
Risk Management Traceability: Risks identified during the development process must be traceable to specific requirements and design inputs which correspond to the risk control measures implemented in the design. Traceability ensures that all identified risks are mitigated through appropriate design or process changes and that these changes are documented and verifiable.
Change Management Traceability: Any changes made during the development process, such as design modifications or process adjustments, must be traceable to the original requirements, risk assessments, and testing procedures. Traceability helps assess the impact of changes on other aspects of the development process, ensuring that modifications do not introduce new risks or compromise compliance.
Regulatory Compliance Traceability: Traceability ensures that all development activities comply with relevant regulations. During audits, traceability allows for easy retrieval of documentation linking each development process step to the corresponding regulatory requirements.
Post-Market Traceability: Traceability is also useful in the post-market phase of a medical device’s lifecycle. Users’ complaints or adverse events must be traced back to the design, manufacturing, or quality control processes. Efficient problem-solving through root cause analysis minimises potential damage caused by non-conformities, and fosters trust among customers and regulatory authorities.
What is a traceability matrix?
A traceability matrix is a critical tool that maps and tracks the relationships between various elements of the ]design and development process](/development/design-controls/). It ensures that all requirements are addressed, verified, and validated throughout the design, implementation, and testing phases.
A traceability matrix is a document establishing clear, traceable links between design controls, often in the form of a table or spreadsheet. Once all the design control information is gathered, it is entered into the matrix, ensuring each user requirement is linked to its corresponding design inputs, outputs, verification, and validation activities. The matrix should be regularly updated to reflect any changes in requirements, design modifications, or results from verification and validation activities.
Components of a traceability matrix include:
- Requirement ID: A unique identifier assigned to each requirement.
- User Requirement Description: A detailed description of the user requirement.
- Design Input: Specific design inputs associated with the requirement.
- Design Output: Corresponding design outputs that address the requirement.
- Verification Method: The method used to verify that the design output meets the design input (e.g., test, inspection, analysis).
- Verification Results: Document the results from the verification activities.
- Validation Method: The method used to validate that the device meets user needs and intended uses (e.g., clinical trials, user testing).
- Validation Results: Document the results from the validation activities.
- Comments/Notes: Additional information or context regarding the requirement, design, or testing activities.
The traceability matrix is the Bible of a medical device development project. It should contain all the information about the device design components and how they relate. The matrix serves as a central document that different teams can reference to understand the status and coverage of requirements, enhancing cross-functional collaboration. Build a traceability matrix early in the project and update it regularly through the development process. This helps to create documentation as the project progresses and identify issues earlier in development.
Why is traceability important?
Traceability is a way of double-checking that everything has been done. It ensures that all regulatory and quality requirements are met and facilitates compliance with standards and regulatory authorities. A traceability matrix ensures that all requirements are considered and addressed during the design and development process, minimising the risk of overlooking critical aspects.
Significantly, traceability streamlines the development process by providing clear documentation and links between all development activities and requirements. This makes it easier to manage changes and resolve issues. It also helps identify, assess, and mitigate risks throughout development, reducing the likelihood of later product failures.
Lastly, traceability provides a framework for generating clear and accessible documentation that can be used in audits, inspections, or reviews. A traceability matrix provides a clear, organised view of how requirements have been addressed, making it easier to demonstrate compliance and the thoroughness of the design process.
Resources
MedDev Central Academy:
MedDev Central Knowledge Hub:
United State of America (USA):
Food and Drug Administration (FDA) guidance document:
European Union (EU):
Medical Devices Regulation (MDR) 2017/745:
- Design and Development is included in the QMS Requirements: Chapter I, Article 10(9)(g)
In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746
- Design and Development is included in the QMS Requirements: Chapter I, Article 10(8)(g)
United States of America (USA):
Food and Drug Administration (FDA), Federal Food, Drug, and Cosmetic Act (FD&C Act):
- Technical documentation requirements are specified in the QMS requirements PART 820.30 Quality System Regulation Procedures: Design Controls
International Standards:
ISO 13485:2016: Medical devices - Quality management systems - Requirements for regulatory purposes, Section 7.3. Design and Development
Change Control: The systematic process of managing and documenting modifications to a device or its manufacturing process to ensure that all changes are assessed, approved, implemented, and tracked in compliance with regulatory standards and quality management systems. This is also known as Change Management.
Clinical Evaluation: A methodologically sound ongoing procedure to collect, appraise, and analyse clinical data about a medical device and to verify its safety and performance, including its clinical benefits. Also see Clinical Investigation.
Conformity Assessment: A process used to determine whether a product, service, system, or entity meets specified standards, regulations, or requirements.
Design Control: A systematic process that ensures a device is designed to meet user needs and intended uses.
Design and Development Plan: A comprehensive document outlining the systematic process and stages, including timelines, responsibilities, and resources, required to bring a medical device from concept to market-ready product, ensuring compliance with regulatory standards.
Design Freeze: The point in the medical device development process where the design is finalised and no further changes are allowed, ensuring a stable basis for validation, regulatory submission, and production.
Design History File (DHF): A compilation of records that describes the design history of a finished device.
Device Master Record (DMR): A comprehensive collection of documents and records describing the medical device’s design, manufacturing, and quality control processes.
Device History Record (DHR): Report confirming that the device is produced according to the specifications in the DMR.
Design Inputs: The physical and performance requirements of a device that are used as a basis for device design. Also known as Technical Specifications.
Design Outputs: The results of a design effort at each design phase and at the end of the total design effort used to evaluate conformance to design input requirements.
Design Review: A formal evaluation process to assess the completeness, feasibility, and compliance of a device’s design with specified requirements (design inputs).
Design Transfer: The process of transitioning a product’s design from development and manufacturing into production while ensuring all specifications and requirements are met.
Design Verification: The process of ensuring that design outputs meet design inputs.
Design Validation: The process of ensuring that devices conform to defined user needs and intended uses.
ISO 13485: An international standard that specifies requirements for a quality management system (QMS) specific to the medical devices industry.
Manufacturer: A legal entity that designs, produces, assembles, or labels a medical device with the intention of placing it on the market.
Post-Market Surveillance (PMS): The proactive collection and review of experiences and data related to a device after it has been released onto the market to ensure continued safety and performance.
Quality Assurance (QA): The systematic activities implemented to ensure that devices consistently meet regulatory requirements and standards while meeting user needs and expectations.
Quality Management System (QMS): A formalised system that documents the structure, responsibilities, and procedures required to achieve effective quality management.
Record: A documented piece of evidence detailing activities, decisions, or results, created and maintained to demonstrate compliance with regulatory requirements and quality management standards.
Regulation: The rules, laws, standards, and requirements set by regulatory authorities to ensure the safety, efficacy, and quality of devices intended for medical use.
Regulatory Authority: An official body overseeing and enforcing laws, regulations, and standards within a specific industry or sector to ensure compliance and protect public interests. Also known as a Regulatory Authority. Also see Competent Authority and Notified Body.
Regulatory Submission: The formal process of submitting documentation and data to regulatory authorities for review and approval to market or sell the device within a specific jurisdiction.
Risk Management (RM): The systematic application of management policies, procedures, and practices to the tasks of analysing, evaluating, controlling, and monitoring risk.
Safety: The condition of being protected from or unlikely to cause danger, risk, or injury.
Standard: A document that provides guidance, requirements, or specifications established by regulatory bodies, industry organisations, or international consensus groups.
Technical Documentation: All documents that demonstrate the design, manufacture, and performance of the device, essential for ensuring compliance with regulatory requirements. This is also known as the Technical File.
Technical Specifications: Detailed descriptions of the requirements, characteristics, and standards that a product, service, or system must meet or adhere to, ensuring clarity and consistency in its design, production, or implementation. Also see Design Inputs.
Traceability: The ability to verify an item’s history, location, or application by means of documented recorded identification.
Traceability Matrix: A document that maps and links requirements throughout the development lifecycle, ensuring that each requirement is tested and validated, thereby demonstrating compliance with regulatory standards.
User Requirements: The requirements and preferences of the intended users, which must be considered and addressed in the device design. Also known as User Needs or Customer Specifications.