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.

Design Controls

Design Controls

If you are developing a medical device, you will need to become familiar with Design Controls. 21 CFR 820.30 states
Breakthrough Devices

Breakthrough Devices

Do you have a medical device that treats or diagnoses a life-threatening disease? If yes, your device may be ...
Regulatory Change Assessment

Regulatory Change Assessment

Making a change to the design or the manufacturing process of your product that is already out in the field? You ...
510(k) Vs CE Mark

510(k) Vs CE Mark

A 510(k) is the most utilized regulatory pathway to market a medical device in the US. For a device of the same ...
What is a Notified Body?

What is a Notified Body?

If you’re considering selling your medical device in Europe, you will need a Notified Body, and you’ll need to ...

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