Medical device CE marking

About us

We are there 4U

CEpartner4U is located in the Netherlands where our team has extensive experience working with manufacturers of all sizes. Our organization serves as consultant and Authorized Representative for hundreds of manufacturers worldwide. In our capacity, we advise manufacturers, their distributors and other stakeholders about the interpretation and application of the European regulations for medical devices. CEpartner4U frequently organizes 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 the 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.

Our organization serves clients across a wide range of areas 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 manufacturers that are looking to CEpartner4U for insight into 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 the manufacturer’s corporate goals.

Not sure if CEpartner4U is the right organization for you? For over 20 years, we have 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 Regulations including the necessary templates, and under our continuous guidance. A similar Entry Package can be offered for the implementation of a quality management system under ISO13485.

CE/QMS Entry packages© >