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Design Process and Quality System Development Tools in Product Lifecycle
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Design Quality: Connecting Design to Documentation
Transform customer complaints to valuable sources of insights for continuous improvement through smart automations and integrated regulatory reporting
Challenges with Triage and Investigation in Complaints Management Process
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Manufacturing Challenges and Industry Trends Towards Digital Transformation
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Frost Radar for Quality Management Systems Names ComplianceQuest Leader
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Why an EHS Solution Built on Salesforce Works Better Than One Built on AWS or Azure
Humans: The Real Superheroes of Artificial Intelligence (AI) in Quality Management
ComplianceQuest Medical Devices QMS Success Stories eBook
Complaint Handling Process for MedTech and Life Science Companies
Audit Management
Aphria (now Tilray) CIO talks about their implementation of ComplianceQuest, Rootstock and Salesforce
Unlocking the Value of Complaints
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The Ultimate Guide to ISO/IEC 17025:2017 Compliance
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Data-driven Safety – Strategic Resources for Monitoring of Key Performance Indicators
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Ensure compliance and streamline development with a traceability matrix for medical devices
ComplianceQuest's powerful cloud-based solution enables seamless tracking of requirements, risks, and tests, ensuring full traceability across the product lifecycle. Stay audit-ready and deliver quality devices with confidence.
A Traceability Matrix is a document that establishes a clear link between various elements of a project or system, typically requirements and test cases. It is a crucial element in Quality Assurance and project management, enabling teams to meet all specified requirements through appropriate testing.
This matrix allows for systematic tracking, validation, and verification of requirements and their implementation, helping to maintain consistency and transparency throughout the project's lifecycle.
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 matrix 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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Read our free guide on the role of the Requirements Traceability Matrix in successful product design. https://www.compliancequest.com/cq-guide/leveraging-rtm/
To create a Requirements Traceability Matrix (RTM), follow these five steps:
A Requirements Traceability Matrix (RTM) is a structured document that should include several key parameters to trace and manage requirements throughout a project effectively. These parameters typically encompass:
Broadly, there are three types of Requirements Traceability Matrix (RTMs): forward Traceability, backward Traceability, and bidirectional Traceability.
The RTM matrix 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 requirements traceability matrix example, 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.
RTM confirms 100% test coverage.
When the Requirements Traceability Matrix is part of a Product Design Management solution, it can highlight, assess, and document all product-related risks and missing or documented inconsistencies.
As a living document with automatic change alerts, RTM acts as a record that holds all design-related parts, requirements, and risks.
Requirements Traceability Matrix can be used to assess and establish risk controls for any identified product risk per part or requirement.
As RTM matrix is an important component of the design control process as defined by ISO 130485:2016, helping with compliance.
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.
Lia Budiman,Continental Contitech
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. For example, a cloud-based file offers 100% traceability as it becomes accessible at 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.
The Ultimate guide to ensuring product compliance with CQ's Requirements Traceability Matrix and product risk solution, and moving from paper-based to cloud-based RTM. Read our guide https://www.compliancequest.com/cq-guide/rtm-and-product-risk-solution/
With ComplianceQuest’s Requirements Traceability and Product Risk solution, medical device manufacturers can:
Achieve complete traceability of product requirements with an RTM matrix 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.
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.
Create a single source of truth with a unified repository to easily access shared records across quality, engineering, and regulatory teams.
Bring product data from other sources to keep quality and engineering teams in sync.
Access the latest inputs, validations, and verifications in the design documents, as all documents are always up to date.
Changes in requirements are instantly flagged to ensure all regulatory and quality standards are met.
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.
Complying with the Regulatory Requirements During Design and Development Stages
Checklist | August 17th, 2022
Understanding Design Controls “Input & Outputs” Requirements
Does your Medical Device Technical File Comply with MDR 2017/745 Requirements?
Checklist | August 24th, 2021
While the Requirements Traceability Matrix (RTM) is mandatory for the design process, it also has its own set of challenges.
If a medical device manufacturer is using a paper-based system to create Requirements Traceability Matrix medical device, they need more tools to improve traceability among teams.
As multiple people have access to the same Requirements Traceability Matrix document, there is a risk of tampering.
In a large-scale setup, traceability increases efforts.
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.
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.
CQ’s RTM offers 100% visibility over links between user requirements, design inputs, outputs, validations, and verifications.
Embedded product risk management helps assess and document all product-related risks and link them to specific parts or requirements.
CQ offers teams a unified repository for all risks and requirements, making them easily accessible to all members.
CQ’s RTM and Product Risks documents are living documents that always remain up to date.
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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