- info@domain.com
- Your location
With former notified body leaders onboard and a team of seasoned experts committed to PERs, we have insights into what advised bodies will acknowledge and strategies for how to answer non-conformities.
The clinical regulatory system is applied during the process to guarantee the outcome meets both your and the informed body’s expectations.
Our team has an exceptional combination of clinical and regulatory expertise, with an understanding of how IVDs work, performance measurements, and what kind of clinical proof and documentation is required.
We have numerous checkpoints with our clients to keep up with alignment, as well as an internal review of the reports to give the high quality PER.
