Design Control Management

The Design Control Management system by Qualcy eQMS offers a streamlined interface for overseeing the design control processes essential for medical device applications. It encompasses several critical components:

• Design and Development Planning: This involves setting project overviews and objectives, defining roles and responsibilities, and scheduling design reviews.
• Documentation of Design Inputs: Captures 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 assessments.
• Design Outputs Documentation: Includes product drawings and specifications, bill of materials (BOM), manufacturing processes, and labeling and packaging specifications.
• Design Reviews: Covers review agendas, attendees, meeting minutes, action items, resolutions, and design review sign-offs.
• Design Verification: Features verification protocols and test plans, trace matrices linking inputs to tests, test reports with data and analysis, and summaries of verification results.
• Design Validation Documentation: Comprises validation plans and rationales, usability testing protocols, clinical data (if applicable), test reports and summaries, and evidence that devices are production-equivalent.
• Design Change Management: Offers 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: Include risk analysis using 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.

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