Profile

My pet peeve was Seven Resourcing Limited. They kept changing domain names and thus evading any filters I would set. After several requests to remove my personal information from their database, I reported them to a European regulator for violations of GDPR (Seven is based, or has affiliates in Europe). ...

I think the below is correct for a 510(k) cleared device, but for a device approved under PMA a submission is required... https://www.fda.gov/medical-devices/premarket-approval-pma/pma-frequently-asked-questions#5

Hi Anon, It really depends on your circumstances. Be aware (if you're not already) that effectively executing clinical studies takes a great deal of resources-especially if they need to be in conformance to GCP or ISO 14155. If you are part of a growing company that expects to be carrying out multiple ...

Hi Anon, Based on experience from something like a hundred CERs written at MED, I agree with the advice you got from Richard and Stephanie, as well as your posted thinking: the company's internal data is almost certainly more detailed than what is in the publication, and those details (as applicable) ...

Good info from Dan, as usual. I'd add that in most cases a manufacturer will have had a number of inquiries from CDRH's signals management group before being slapped with a 522 order. This tool is usually (always?) applied to 510(k) cleared products. It's also relevant to note that postmarket requirements ...