Biocompatibility Requirements Review

Context

Checking whether IP22 was mandatory for the FDA submission meant confirming the specific IP rating and IEC 60601 requirement for that jurisdiction directly, rather than assuming it matched another market's rule.

Primary Risks Identified

• Assuming a compliance requirement is universal across markets when it is in fact market-specific, leading to a missed requirement in one jurisdiction

Testing Approach

Verified the specific regulatory requirement against the applicable market's current standard or guidance (IEC 60601, Health Canada, or biocompatibility requirement), applying root-cause techniques where a recurring gap needed resolving.

Outcome

Confirmed the applicable IP rating requirement (IP22) and IEC 60601 compliance status for the FDA submission, closing the open compliance question.

Key Lessons

An IP rating requirement (e.g. IP22) can be mandatory in one jurisdiction and only recommended in another, the compliance check has to confirm the applicable requirement per market, not assume it's universal.