Resource Center

Find the latest content and resources from our team of experts to keep you in the know for all things quality and regulatory in the life science industry.

EU MDR Delays

EU MDR Delays

It is no surprise to anyone in the medical device industry that the transition from EU MDD to EU MDR has seen ...
Annual Drug Product Reviews

Annual Drug Product Reviews

If you are a drug manufacturer in the US, an Annual Drug Product Review (ADPR) should be familiar to you. ADPRs ...
De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the ...
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration ...

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