“EUROPECERT performed a facility GMP audit at our unit in Rennes, France for identifying GAPs in the 21 CFR 820 Implementation process and we were very pleased with the report provided. It was comprehensive, practical and clearly indicative of what was actually missing and what an FDA inspector would look for in 21 CFR 820. We are appreciative of the level of service we received at very reasonable rates.”

“I’m really pleased with the service and support I received from EUROPECERT. The team has clearly identified the device classification and made the necessary modification in the naming as per FDA Product Code. They helped us to complete the registeration and listing with USFDA within 14 working days."

"I've worked with EUROPECERT, Germany for the technical file preparation of our medical device with an ancillary drug. The team involved was technically sound, friendly & cooperative. The team used a cloud-based software, so that all developments were timely discussed and corrected. This helped us to close the project before schedule.
Thanks again for your help on the project,

My experience with EUROPECERT has been great, everyone is open to answering technical questions, even at any time of the day! I’m looking forward to working with them for the transition to the new Medical Device Regulation (MDR).

I've had a great experience working with EUROPECERT. They helped us to resolve DNV NB quries immediately and we got the approval letter in short duration. The consultants working from Germany & India are always available for guidance and to answer any questions. I definitely recommend EUROPECERT, if you are looking for technical support for regulatory compliance.

My wife and I recently started a Medical Device Manufacturing business by identifying an OEM from China. It has been a great experience throughout the process of ISO 13485 & OBL CE Certification for us and we would recommend EUROPECERT to anybody looking to start OBL CE Marking. The CE Consultants are especially helpful and always available to answer any questions that we have. As a whole, EUROPECERT has been enjoyable to work with. Everybody who we interacted with has always been professional and courteous. Emails get answered quickly and respectfully. We look forward to working with EUROPECERT for the surveillance audits!