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.

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 ...
At Home Medical Devices

At Home Medical Devices

When most people hear the term “medical device”, they think of surgical and hospital tools, like stethoscopes or ...

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