Heraeus offers fully integrated solutions with capabilities across the full spectrum of design, product/process development and documentation, Regulatory Affairs and high volume/low cost manufacturing.
With the experience of 13 US FDA 510(k) clearances and several product lines with EU CE Mark, Heraeus is able to facilitate getting your device to market quickly and more efficiently.
Heraeus employs teams steeped in medical device expertise, many coming from world-class medical device companies so our team understands the challenges that you face. A strong medical advisory group is maintained to supplement clinical expertise and to provide feedback on everything from product performance to long-term trends in clinical practice.
Finally, Heraeus offers the full range of in-house product performance testing to support the design and development process as well as compile the testing required to secure regulatory clearances and approvals. Doing this in-house, we are able to drastically reduce development and regulatory timelines.