Jim Talbot

“I would highly recommend Celegence for any EU MDR compliance related projects.

I reached out to Celegence to help my company prepare for an upcoming MDR assessment for CE Certification in late April. The timeline was very short and the deliverables requested were substantial. We needed a rewrite of our Clinical Evaluation Report (CER) as well as a Gap Analysis of our Technical Documentation to the new EU MDR within 2 months. The feedback was very detailed and actionable allowing us to quickly address all deficiencies within a week. Similarly, the CER prepared was top notch with all of the appropriate hooks in place to allow compliance with the new EU MDR. All in all, I would highly recommend Celegence for any EU MDR compliance related projects.”