3951 DB Maarn
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).
is your independent Authorized Representative, confidentially maintaining your technical files and registering your Class I and IVD products with the Dutch Competent Authority.
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