5 Design Change Considerations to Stay Compliant - Webinar Recording/Transcript
5 Design Change Considerations to Stay Compliant
Medical device design change is a demanding and uneasy process. Failure to dot all your i’s and cross all your t’s can lead to inspection problems on the downside and missed market opportunities on the upside.
FDA QSR §820.30(i) spells out the basics but 820.30(i) is only the starting place for you and the team. FDA’s QSIT tells investigators that production and process changes under §820.70 may also be design changes under §820.30(i). Also in play: 21 CFR §820.75 and ISO 13485:2016. It’s complicating your processes.
Here to straighten things out is Dan O’Leary, FDAnews’s expert on all things technical involving medical devices — and one of our most sought-after presenters.
- Relationship among design output, design transfer and production control
- Reason why the FDA may deem a production change to be a design change
- Elements of the new UDI rule including the Device Identifier (DI)
- Triggers that create a new DI and how to document your decision
- Requirement to evaluate change significance for possible 510(k) submission
- Use of the 510(k) change guidance documents
- Changes to the risk management file resulting from a design change
- Implications for FDA inspections
Special Bonus Materials: Checklists you will use to ensure effective implementation.
If your responsibilities include production and process changes, then you need to determine whether they are design changes and how to implement them. If they include design changes, then you need to understand all the considerations for a complete and compliant change and the associated records. And that’s exactly what you get when you check in with Dan O’Leary!