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Do you control design changes differently during pre-transfer segment of design and development project, during design transfer and after product release?
All changes must be reviewed and approved, but how much control is necessary prior to verification and validation. During the verification and validation activities there is a cost to your business, but there is no impact on safety or efficacy. However, once a product is released to market more stringent change control is necessary. The best design procedures articulate these important differences as a risk-based control of design changes. How do you plan to update your design control procedures for compliance with ISO 13485:2016, Clause 7.3.9?
Please share what you think are the best approaches to address this dilemma.
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Ivan Liljegren For medical device software, we try to stick to quarterly releases, where we run through the full V&V cycle. The extent of V&V activities can be reduced depending on scope of the release (e.g. UI changes, functionality changes, integrations, bug fixes) and the associated impact. For medical device hardware, all changes are controlled through the PLM system and safety critical components are specially flagged as such. Any change affecting those components would require additional regulatory review and approval.
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David Meeks One practice we have used is to apply a different level of risk impact evaluation at successive stages of development. Prior to clinical evaluations, change control is fairly fluid, with most risk/impact analyses focusing on impact to the project moreso than the product.
After a clinical investigation, however, any design changes need to be adequately evaluated by Medical as well as R&D and Quality to ensure that the design change does not impact the validity of the clinical trial. Here, then, a more formal, FMEA-type risk analysis is applied with a broader audience. During or after formal V&V, the changes to the process are not significant, since the formal FMEA-style approach is fairly robust, but more stakeholders get involved. Late change impact business commitments and project deadlines, so higher levels of management get a voice. Once formal design transfer has started (or earlier if special tooling is used), any changes must include stakeholders from product supply.
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Actually, I would debate that once you enter clinical trials, the device design must be frozen. My expectation is (and the regulatory requirement thereof) that the clinical trials are performed as a part of the design validation. By defacto, this then means that the design should have already been fully qualified and verified with robust statistical sampling and testing.
If you launch a clinical trial and then discover that a design change must be made regardless of how subtle or for whatever reason - you risk completely invalidating the trials.
With these thoughts being said, the design control processes must be established such that they incorporate a design freeze. Design freeze must occur before validation.
In the sense of 510k and PMA work - especially the latter - not only must the design be frozen prior to validation, but so must all manufacturing processes. This means too, that design transfer should never occur if design changes are still pending.
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