About us

We are there 4U…

CEpartner4U services include on-site and cyber consulting for all products under the medical device directive (MDD), in-vitro diagnostic device directive (IVDD) and active implantable device directive (AIMDD).

CEpartner4U is your independent Authorized Representative, confidentially maintaining your technical files and registering your Class I and IVD products with the Dutch Competent Authority.

CEpartner4U is staffed with a team of experienced Lead Assessors and medical equipment researchers. Their experience includes:

  • Project engineering for a major Dutch medical research organization.
  • Managing a multitude of medical consulting projects and training programs include medical product development, market research, development of quality test programs for medical devices, ISO 13485, GMP, hospital quality standards and CE-marking of medical devices
  • ISO 13485 and sterilization processes assessment and several years of medical device directive (MDD) audits in Europe, Israel and the USA as certified lead assessor for a Notified Body

 

Office

CEpartner4U
Esdoornlaan 13
3951 DB  Maarn
The Netherlands
+31.6.516.536.26
www.cepartner4u.com
office@cepartner4u.com
CoC: 27242307
VAT: NL807005332B01

 

Team

Mr. Ton Pennings
Director
P.  +31(0)343.444.875
M. +31(0)6.516.536.26
t.pennings@cepartner4u.com
Mr. Rogier Nusselder
Senior Consultant Medical Devices
Ph  +31(0)343.441.156
M. +31(0)6.292.06.392
r.nusselder@cepartner4u.com
Mr. Theo Nusselder
Member of the board
P.  +31(0)343.442.524
t.nusselder@cepartner4u.com
Ms. Olga Teirlinck
Consultant Medical Devices
P.  +31(0)343.441.570
o.teirlinck@cepartner4u.com
Ms. Kitty ter Borg
Consultant Medical Devices
P.  +31(0)343.445.524
M. +31(0)628.484.299
k.terborg@cepartner4u.com