When you need a team with broad experience and knowledge who really wants to get your medical product idea to the market where it can help patients, we are ready to collaborate. Contact us to learn more and to discuss what we can do to help guide your project through the medical device product lifecycle.
European notified bodies have recently started requiring B1+RMS limits on MR Conditional labeling. This requirement stems from...
Medical device manufacturers should always refer to ISO 10993 Series of Standards in addition to region-specific regulatory...
FDA recently issued a Letter to Industry regarding medical device submissions that contain fraudulent and unreliable third-party...
OUR COMMITTMENT
We are committed to consistently performing services with high quality, that deliver exceptional results, and add value to the client’s business.
For client surveys sent in the last two quarters, we received ratings of 4.76/5 points (10).