Regulatory

JE Petersen provides value-add service to our customers by providing regulatory support. Whether you need assistance preparing a 510k, or you’re simply trying to make sure you comply with European environmental standards, we can help you navigate the difficult hurdles that medical device companies must overcome.

We can help you build and maintain your Design History File (DHF), prepare test protocols, test and validate, and even write your 510k application. Our manufacturing service includes Device History Record (DHR) documentation and tracking in our cloud-based quality system, which you can access 24/7/365.

Finally, we can help you with mandatory medical device complaint reporting. The hurdles for medical devices are many, but JE Petersen can lead you through them.