Over the years, manufacturers in the medical, technology, and engineering industries have witnessed several regulatory changes. Manufacturers in these industries have several steps in the production and designing process that needs to be meticulously documented. Any business that has a long list of steps will benefit from having a requirement analysis tool. For medical device manufacturers, a traceability matrix is part of the Quality Management System. RTM is part of the design and development cycle of any medical device as it gives a broad view of the user needs and how these are included and verified in the device manufactured.
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Requirements Traceability Matrix (RTM)
What is a Requirement Traceability Matrix (RTM)?
A Requirement Traceability Matrix (RTM) is a document that helps track the design requirements and verify if the current project requirements are met. RTM is used to prove that design requirements are fulfilled. It documents design requirements, tests, test results, and issues. RTM is essential for a medical device’s design and development cycle as it gives a high-level view of the connections between user needs and specifications. Requirements Traceability Matrix (RTM) helps ensure that the user requirements meet test cases by capturing all requirements gathered from the client in a single document. Medical device manufacturers use a requirement traceability matrix to ensure the device is reliable and effectively meets the needs of its intended use. The ability to demonstrate traceability plays a critical role in the submission of the medical device for regulatory approval.
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Why is RTM Matrix required?
Requirements Traceability Matrix is essential to keep track of the actual design process. It helps prove that the design satisfies the user’s needs and helps identify areas where improvements are necessary. Requirements Traceability Matrix is important for product development and to remain compliant with ISO 13485:2016.
Benefits of Requirement traceability matrix in the medical device lifecycle
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RTM confirms 100% test coverage.
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When Requirements Traceability Matrix is part of a Product Design Management solution, it can highlight, assess, and document all product-related risks and missing or document inconsistencies.
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As a living document with automatic change alerts, RTM acts as a record that holds all design-related parts, requirements, and risks.
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Requirements Traceability Matrix can be used to assess and establish risk controls for any identified product risk per part or requirement.
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As RTM is an important component of the design control process as defined by ISO 130485:2016, helping with compliance.
Features of CQ’s Requirements Traceability and Product Risk
- A Requirements Traceability and Product Risk system offers a range of features to support efficient product development.
- Improve requirements traceability within the organization by capturing and linking all requirements, inputs, outputs, validations, and verifications throughout the product lifecycle. This ensures that each requirement is accounted for and can be traced back to its origin, helping teams
- Automatic changes alert to easily spot changes to product requirements to ensure all required steps are taken.
- Use CQ’s robust product risk management capabilities to identify and document product-related risks, assessing their potential impact on the project. This includes classifying risks per part or requirement, evaluating their severity, and prioritizing mitigation efforts accordingly.
- Establish and assess risk controls to mitigate identified risks, reducing their likelihood or impact. This may involve implementing design changes, conducting additional testing, or implementing safety measures.
- Facilitate residual risk assessments, which evaluate the remaining risks after implementing controls. It helps teams monitor and manage residual risks, ensuring appropriate actions are taken to minimize their potential impact.
- An easy-to-use platform that improves team collaboration.
Uses of RTM
- As RTM is applicable through the entire lifecycle of the product, it helps simplify defects triage.
- Test case management can be simplified using Requirements Traceability Matrix as it helps map source requirements and the defects it helped identify.
- As a product design goes through many iterations throughout the product process, cloud-based RTM helps improve version control to ensure there is no loss of data or miscommunication between teams.
- By using a cloud-based product management tool to create Requirements Traceability Matrix, product data from other sources, including the ERP Jira, can be included in the RTM to keep quality and engineering teams in sync.
- RTM helps the project manager create adequate documentation from design input to verification and validation throughout the product lifecycle.
What are the different types of Requirements Traceability Matrix (RTM)?
Broadly, there are three types of Requirements Traceability Matrixs (RTMs): forward Traceability, backward Traceability, and bidirectional Traceability.
- Forward Traceability helps map each requirement to a test case to establish that every requirement from top to bottom is being tested while confirming the project has a sound trajectory.
- Backward Traceability Matrix helps map test cases with design requirements to avoid going beyond the initial requirements.
- Bidirectional Traceability combines forward and backward Traceability into one document to establish each requirement with a relating test case.
Requirements Traceability Matrix (RTM) example
The RTM helps demonstrate traceability between requirements and critical design elements, ensuring that safety-critical aspects, such as the accuracy of drug delivery and alarm systems, are properly addressed.
For example, a medical device manufacturer developing an infusion pump must prepare RTM to ensure all project requirements are successfully traced and implemented throughout the project lifecycle. In this case, the RTM would capture all the functional and safety requirements for the device, including sensors to measure flow and pressure, connectivity parameters for telemetry gateways and patient monitoring, fluid pump control, and battery life.
RTM will also capture all the associated regulatory standards and guidelines. Each requirement would be linked to design specifications, risk assessments, verification and validation activities, and relevant documentation.
How to create a Requirement Traceability Matrix?
To create a Requirement Traceability Matrix (RTM), follow these five steps:
- Define the goal or the ‘why’ of the medical device based on user needs. This step helps create a design that directly addresses the need of the customer.
- Once the goal is defined, the user need must be translated into quantifiable design inputs that can be achieved during production. In this step, it is important not to use ambiguous terms.
- Design output should meet design inputs to ensure all parameters defined are met consistently.
- Elaborate on the measures or steps taken to verify that the design meets the specifications.
- Clearly justify how the end-to-end design output meets the user need initially discussed.
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We have rolled-out CQ across our company to automate various elements of QMS requirements such as Document Management, Complaints, Non-conformances, Corrective Action (8D and A3), Supplier Management and Audit Management. We have been using the software for more than 2 years. We are glad to see how well the system is being used across the company. We have several thousand users on the system currently and working to scale the usage further. CQ solution has been configured to meet our needs, works elegantly across languages, across time zones, and business verticals. With integration between CQ and SAP to exchange critical data, the process automation provides a lot of productivity.
CQ configuration team and support have worked hard to ensure that our needs continue to be met. They consistently go above and beyond. We cannot be more pleased with our use of CQ QMS capabilities and would definitely recommend to anyone who is looking for a modern cloud based EQMS solution especially if you want a scalable EQMS solution.
Why should RTM become a cloud-based file?
Teams need complete visibility to track, modify, and manage design inputs and outputs, product risks, validations, and verifications. A paper-based Requirements Traceability Matrix (RTM) or excel-based system creates silos that affect the design development process. As the name suggests, RTM focuses on traceability. A cloud-based file offers 100% traceability as it becomes accessible any time anywhere during the entire lifecycle. By using a cloud-based RTM file, teams can assess, identify, and mitigate all product-related risks without any loss of data or records. ComplianceQuest’s Requirements Traceability and Product Risk solution helps the entire organization. The solution supports:
Embracing the cloud empowers organizations to leverage the full capabilities of RTM, leading to enhanced efficiency, agility, and operational excellence.
Gain seamless access from any location, promoting collaboration and enhancing productivity. Team members can effortlessly view and update monitoring data in real time, leading to improved decision-making and rapid response to critical events.
Achieve scalability as the system can effortlessly adjust storage capacity based on their needs. It eliminates the burden of hardware maintenance and data backups, ensuring data integrity and security.
Integrate with other cloud services, enabling advanced analytics and integration with emerging technologies like AI and machine learning, amplifying its potential.
Leverage data security and reliability, ensuring data protection and compliance. Regular backups and disaster recovery options further enhance data integrity and business continuity.
Where can RTM be implemented?
CQ’s RTM creates 100% visibility. Requirements Traceability Matrix helps medical device manufacturers improve the design process by creating links between user requirements, design inputs, outputs, validations, and verifications. As Requirements Traceability Matrix is an important component of a product lifecycle, it must be available to all teams, including engineering, quality, and regulation, to ensure a smooth design process.
How can ComplianceQuest’s Requirements Traceability and Product Risk solution help improve collaboration?
With ComplianceQuest’s Requirements Traceability and Product Risk solution, medical device manufacturers can:
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Achieve complete traceability of product requirements with a Requirements Traceability Matrix (RTM) file that is always up to date. CQ’s Requirements Traceability Matrix (RTM) offers complete visibility over links between user requirements, design inputs, outputs, validations, and verifications.
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With embedded product risk management, identify and control all product-related risks to implement the appropriate risk controls along with residual risk assessment for full compliance.
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Create a single source of truth with a unified repository to easily access shared records across quality, engineering, and regulatory teams.
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Bring product data from other sources to keep quality and engineering teams in sync.
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Access the latest inputs, validations, and verifications in the design documents, as all documents are always up to date.
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Changes in requirements are instantly flagged to ensure all regulatory and quality standards are met.
Achieve complete traceability of design process with ComplieceQuest’s Requirement traceability matrix (RTM) and reduce the risk involved in the process.
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Frequently Asked Questions
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While Requirements Traceability Matrix (RTM) is mandatory for the design process, it also has its own set of challenges.
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If a medical device manufacturer is using a paper-based system to create Requirements Traceability Matrix, they need more tools to improve traceability among teams.
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As multiple people have access to the same Requirements Traceability Matrix document, there is a risk of tampering.
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In a large-scale setup, traceability increases efforts.
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Without the right set of tools, understanding the Requirements Traceability Matrix (RTM) can become a tedious and time-consuming process for teams.
Moving away from a manual RTM can help resolve many of the challenges. With ComplianceQuest’s Requirements Traceability and Product Risk solution, medical device manufacturers can create a living design file that improves teams’ collaboration, version control, traceability, and compliance.
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Medical device manufacturers must understand the importance of a traceability matrix as defined by ISO 13485:2016 under Design Control traceability. The Requirements Traceability Matrix is an excellent internal tool for project management that ensures that the team has access to design history and ensures nothing is left undeveloped during the Design Control process. The medical device manufacturer can use RTM to view the entire design history, including evidence of quality controls to ensure that the design goals are duly met.
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CQ’s RTM offers 100% visibility over links between user requirements, design inputs, outputs, validations, and verifications.
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Embedded product risk management helps assess and document all product-related risks and link them to specific parts or requirements.
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CQ offers teams a unified repository for all risks and requirements, making them easily accessible to all members.
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CQ’s RTM and Product Risks documents are living documents that always remain up to date.
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Engineering and quality teams must always have access to the latest inputs, validations, and verifications. With CQ’s RTM solution, teams can work together to ensure all user requirements are met, and the Product Risk document ensures all product-related risks are thoroughly recorded and addressed.
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