Combining regulatory requirements and updating the SOPs through CAPA surfaced a biocompatibility statement that had been reused across IFUs for UAE and India without re-checking either market's specific requirement.
One statement, two markets, two requirements
UAE and India can both require a biocompatibility statement on the same class of device and still expect different content. Reusing one statement across both IFUs assumes a match that was never actually verified.
- Verifying the specific regulatory requirement against the applicable market's current standard or guidance
- Applying root-cause techniques (5-Whys) where a recurring gap needed resolving
- Aligning label and IFU content to each market's specific requirement
Where the assumption breaks
Assuming a compliance requirement is universal across markets when it is in fact market-specific leads to a missed requirement in one jurisdiction, exactly what the CAPA was opened to catch.
What the review delivered
Reviewing and updating the biocompatibility requirements for the affected markets aligned label and IFU content to each market's specific requirement, closing the CAPA.
The Real Takeaway
Biocompatibility and labeling requirements differ enough between markets that a single statement can't be reused across IFUs without re-checking each market's specific requirement.
The SOP update through CAPA exists specifically to catch that kind of unverified assumption.