Q: Are there any FDA regulations or requirements that cover the tracking and recording of exchanged parts used in equipment such as medical devices? A: The current answer depends on whether you are servicing the device, remanufacturing it, or refurbishing it. If…
Tag Archive for design output
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 Change: How Does FDA Define It?
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Q: From an FDA viewpoint and your own experience, how would you recommend we define a “design change” in our design control procedures? A: FDA has said that any change to the finished, packaged and labeled device should be considered a design…
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…
Essential Design Outputs: How Does FDA Define Them and What are Some Examples?
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Q: I need guidance on 21 CFR 820.30(d), where the regulations talk about Essential Design Outputs. I’ve been getting a lot of hot air about this requirement. Could you give some examples, especially for an electromechanical device and a sterile disposable device?…
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…