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Hello, I have used Idem Translations (https://idemtranslations.com/)  exclusively throughout my 25-year career in medical devices. I have referred them to many companies and have only heard glowing reviews. If you have specific questions, please feel free to contact me. Julia ------------------------------ Julia Brown Sr Manager, Regulatory Affairs ...

There are a few consequences of varying types: - if you have a pending PMA that will be made at the facility, no PMA clearance until warning letter resolved - inability to get new "Certificate to Foreign Government" to support OUS registrations - primarily because you cannot attest that all of your products are "in compliance" as required to get these ...

You've gotten some great advice here and I agree with that. My additional thought is that I would like to think that the reviewer is aware of the competitors product situation. Therefore, you just have to make sure that you and your review team are on the same page on that. But it's possible, especially with everyone working remotely now, that the team ...

Hello Anon ​Just because two devices can be used together, or just because you have decided to market them together, they are not necessarily a system or a kit. Some collections of devices are pretty obviously kits or systems, some are obviously not, and sometimes it's gray. For EU, read through the definitions in MDR Article 22. For US, read the guidance ...

I agree with Dan, in this case, it is critical to be as precise as possible when referring to the country if you are using country standards. I prefer not to use country standards, on my first cut when possible, by using International standards (IEC/ISO/ASTM) starting as the majority of the requirements are covered in these standards and then I add ...