eQMS

Design Control Management

Qualcy eQMS offers a straightforward interface for overseeing the design control process tailored for medical device applications. It encompasses several key areas:

• Design and Development Planning: This includes project overviews, objectives, roles and responsibilities, and a schedule for design reviews.
• Documentation of Design Inputs: Covers user needs, intended use, regulatory requirements (such as FDA and EU MDR), functional and performance requirements, interface requirements (mechanical, electrical, software), human factors, usability considerations, and risk control measures linked to hazard risk assessment.
• Design Outputs Documentation: Involves product drawings and specifications, bill of materials (BOM), manufacturing processes, and labeling and packaging specifications.
• Design Reviews: Includes review agendas, attendees, meeting minutes, action items, resolutions, and design review sign-offs.
• Design Verification: Features verification protocols and test plans, trace matrix linking inputs to tests, test reports with data and analysis, and a summary of verification results.
• Design Validation Documentation: Comprises validation plans and rationale, usability testing protocols, clinical data (if applicable), test reports and summaries, and evidence that devices were production-equivalent.
• Design Change Management: Provides options for change request forms, impact assessments, revised documents (inputs, outputs, test results), re-verification and/or re-validation evidence, and change approval signatures.
• Risk Management Files: Includes risk analysis with FMEA and ISO 14971 for hazard identification, risk control measures, and residual risk acceptability.
• Traceability Matrix: Maps design inputs to outputs, verification and validation activities, and links risk analysis to controls and tests.