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.

FDA Establishment Types

FDA Establishment Types

‌  When registering a medical device with the FDA the type of product influences the method of pre-market ...
510K Submission Tips

510K Submission Tips

‌  Registering a new device with the FDA can be tricky. The first step is to choose what pathway to follow ...
Making a Change to a QMS

Making a Change to a QMS

‌  A Quality Management System (QMS) is often designed well before a company starts the development of its ...

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