PORTFOLIO
The vast majority of our clients over the years can be characterized primarily as USA-based Blue Chip medical device manufacturers and venture capital funded medical device innovators.
For these USA-based medical device manufacturers, we collaborated to assure compliance of clinical investigations with applicable European and FDA regulations. Frequently, our European investigations are the first clinical evaluations of these products. Our clients have used these initial clinical results to their advantage to:
- provide clinical experience data to successfully support 510(k) applications to the FDA
- Provide supportive clinical data in the negotiation of clinical trial designs within the IDE approval process with the FDA
- Provide pivotal clinical data in support of PMA applications
- Obtain positive conformity assessment, CE-Certification and European market introduction
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