About us

We are there 4U

CEpartner4U is located in the Netherlands where our team has an extensive experience working with clients from small sizes to world leaders. Our organization serves as consultant and Authorized Representative under the European Medical Devices Directives for hundreds of manufacturers from all over the world. In our capacity, we advise clients, their distributors and other stakeholders about the interpretation and application of the European regulations for medical devices. CEpartner4U is a frequent organizer of seminars and training, addressing a variety of topics including regulatory- and legal affairs, marketing and operations. Although the European market is well known, constant changes in union legislation, as well as the associated changes in quality requirements make it challenging for companies to stay abreast of the developments in this unified continent. That is, apart from anticipating to the various cultures and languages. Our organization serves clients across a wide range of segments in the medical field. We have experience with:

  • Active and Passive Implants
  • Cardiovascular
  • Neurology and Neurosurgery
  • Gastroenterology and Urology
  • Obstetrical and Gynecological
  • General and Plastic Surgery
  • Radiology
  • Ear, Nose, and Throat
  • Ophthalmic
  • Orthopedic
  • General medicine
  • Physiotherapy
  • Dental
  • Software
  • IVD

And more…

Our staff in the Netherlands answers to companies that are looking to CEpartner4U for insight in areas such as long-term strategic direction, quality systems and regulations. Our services range from Authorized Representation to vigilance reporting, from self-supporting tools to extensive consultancy. All tailored to your corporate goals.

Not sure if CEpartner4U is the right organization for your requirements? For almost 20 years, CEpartner4U has been a preferred European regulatory affairs partner of hundreds of organizations in the life sciences industry. A simple and cost effective way to get to know us is by means of our CE Entry package©, an effective and efficient electronic seven-step system to implement the requirements of the Medical Devices Directives including the necessary templates and with our continuous guidance. A similar Entry Package can be made available for the implementation of a quality management system under ISO13485.