The path to regulatory approval is long and arduous. Gezell works with clients to develop multi-site ethics-approved clinical research projects. These are not only critical to demonstrate device safety and efficacy, but positive clinical results can provide the "white coat credibility" your company needs in order to open up key target markets.
We are also very experienced with the "other side" of regulatory affairs: Your products will need to have the right certifications for product safety, bio-compatibility, EMI susceptibility and emissions compliance, RoHS, etc.
Is your QMS ready for prime time? Today's MedTech companies need to navigate an alphabet soup of procedural compliance: ISO-13485 QMS, ISO-41971 Risk Assessment, ISO-62304 Software Development Process, etc. Let us help you!