Testimonials

Celegence - Testimonials and Reviews from Clients

Client Testimonials

When working with clients we always aim to exceed expectations and here you can see some honest testimonials and reviews from our clients.

Like all companies serving the Life Sciences industry, our success in business is defined by our skillset and reputation. We are confident that the team of experts we have assembled can assist manufacturers through the regulatory process and below you can view some testimonials from clients to give you an insight into our reputation.

Zap Surgical - Testimonial Celegence

“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 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 (by the end of June).  Our product is a complex linac based radiosurgery system that is used to treat tumors and other conditions in the head, neck and brain.  Celegence assigned a team for each task and within a month had provided the Gap Analysis for our Technical Documentation including our IFU, Declaration of Conformity and Labeling.  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.  The expertise and experience that their team possess is outstanding.”

Jim Talbot - Vice President, RA/QA, Zap Surgical
Kavo Kerr - Testimonial Celegence

“The Celegence team has provided services to meet MDR compliance through high quality CERs in both a timely and cost-effective manner for our Medical Device portfolio. We look forward to a continued partnership in this compliance journey.”

Dr. Carlos Munoz-Viveros - Director, Clinical Affairs, Kavo Kerr Group

“Celegence’s team serves as an extension of our internal publishing and compliance team and has allowed us to achieve significant time and cost savings in comparison to our previous regulatory partners.”

Hervé Rique - Director of Safety & Regulatory Information Management, Stallergenes, France