Verification and Validation at Compass Health

Compass Health SOP: Verification and Validation

• This SOP outlines the verification and validation (V&V) process for medical device production at Compass Health
• The V&V process is crucial throughout product development, starting early in design and continuing near completion
• V&V activities employ various methods, from design reviews to analyses, inspections, demonstrations, and tests.
• The process ensures all design and development outputs meet customer requirements
• Scope includes V&V activities throughout the product design phase, ensuring that design and development meet input requirements
• Production process is governed by SOP: Process Validation (QMS-SOP-0017).
• Distribution and feedback are governed by SOPs: Post Market Surveillance (QMS-SOP-0030) and Feedback and Customer Satisfaction (QMS-SOP-0022).
• Applicable standards and regulations include FDA QSR § 820.30 Design Controls, ISO 13485:2016 Section 7.3 Design and Development, IEC 62304:2015 Medical Device Software – Software Life-cycle Processes and TG (MD) R Sch3 P1 Cl 1.4(4)& (5)(c)
• Different roles (Engineering, QA, Product) have specific responsibilities related to different aspects of verification and validation, including defining strategies, conducting activities, and ensuring coverage.
• V&V process proceeds according to a high-level flow chart(Figure 1), typically with review gates
• The V&V plan details all V&V activities for a given product
• QA approves V&V plans ensuring requirements, risk analysis and hazard mitigations(product Risk Management Plan are covered)
• V&V activities occur throughout different product development phases and development methods (Agile/Traditional).
• V&V activities are documented at each phase, and product V&V plans are regularly monitored.
• Compass uses different V&V methods (e.g. Review of Design, Analysis, Inspection , Demonstration , Tests, Clinical/Performance Evaluation) depending on the complexity of the task and specific requirements
• Review of design, analysis, inspection, demonstration, and testing are different V&V methods
• Methods are selected in agreement with QA, Engineering and/or Marketing (for labelling and packaging).
• Clinical or performance evaluations take place after successful verification to validate safety and performance.
• Production and Distribution SOPs validate production and distribution processes
• Traceability methods document connections between tests and requirements for each product and new features.
• Quality records such as V&V plans and test results are maintained
• Product development plans specify which phase of the review needs which V&V activities.

This quiz tests your understanding of the Verification and Validation (V&V) process at Compass Health. Learn about the purpose, timing, governing documents, and responsibilities involved in V&V activities during product development. Dive into the specifics of the standards and SOPs guiding these processes.