Call Us Today at 508-231-8842                EMERGENCY

Pre-Sub Process Recommendations

Pre-Sub Process Recommendations

A Pre-Submission (or Q-Submission) is a structured process for developing interactions between medical device manufacturers and FDA about a myriad of topics that ultimately point to future applications for approval or clearance, prior to the IDE, 510(k), PMA, or De...
New and Important Distributor Requirements Under EU MDR

New and Important Distributor Requirements Under EU MDR

European Union (EU) medical device regulations (EU MDR) have significantly increased the requirements for distributors. If you are currently a distributor of medical devices in the EU, or are considering doing so, it is important that you understand these new...