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Hi Joshua, I've done several Class II licenses recently and I agree with the other members - they're very quick to review and issue licenses, provided the application is complete.  In my experience, the applications are reviewed and approved within their performance target timeframes (around 15 days). ...

Hi Akanksha, A designated small business is eligible for a reduced fee for some types of CDRH submissions that require user fees.  Some examples are PMA, 510(k), De Novo, BLA.  To qualify as a small business the business, including any affiliates, must have gross receipts and sales of less than $100 ...

Hi Anon, This is a good topic to bring up to get other members' current experiences as there is definitely some disruption happening in this space. The MDSAP procedure you posted is limited to remote auditing of only one chapter of the audit (Device Marketing Authorization and Facility Registration ...

Hi Anon, The names of these forms may be specific to certain auditing organizations.  In my experience, a Z1 visit receipt & A7 coversheet was signed after both stage 1 and stage 2 MDSAP audits, as was the case for prior ISO 13485 audits.  There is no template or link to download from because these ...

Hi Karen, I have been in a similar situation before, as an ISO 13485 certified manufacturer utilizing an ISO 9001 certified contract manufacturer.  Ideally, they would also be ISO 13485, but as you mentioned, most seem to have ISO 9001.   Since the risk of this supplier was high, I created a supplier ...