Q: Really, in the final analysis, isn’t design validation just user testing? A: I’ve heard that a lot lately. But it’s not true. The Quality System Regulation (21 CFR Part 820) includes requirements for design controls. The regulation requires design validation…
Tag Archive for design input
Determining What’s “Production Equivalent” with a New Product Design
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Q: I’m dealing with a design contract house responsible for product design of a medical device. They are responsible for all of the documentation needed for design control, etc. If we produce the first 100 units via the contract house, those units will be…
Can Characterization Substitute for Design Verification?
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Q: We have characterized a material change to our medical device and have confirmed there’s no impact to any of our design inputs or outputs. Do we still have to formally perform Verification and Validation (V&V)? In other words, is the…
Design Changes: When It’s OK to Verify but Not Validate
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Q: My colleagues and I are having a discussion about design changes. We have characterized a material change to our medical device and have confirmed there’s no impact to any of the product’s design inputs or outputs. In this case, do we…
Audit Suppliers for Design Control Compliance: Do’s and Don’ts
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Q: When we need to audit suppliers for design control, what’s the best approach for doing the audits, and what main documents should we review? A: To audit a third-party design facility, first ensure it’s registered with the FDA and has a Quality…
How to Audit Suppliers for Design Control Compliance
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Q: When we audit suppliers for design control, what’s the best approach for doing the audits? And what main documents should we review? A: To audit a third-party design facility, first ensure it’s registered with the FDA and has a Quality…