Expertise

The expertise of Groots In Vitro Diagnostic Expert is gained through:

Over 14 years’ experience in the medical device industry

Broad experience with Quality Management Systems and Market Access of various (in vitro diagnostic) medical devices:

• At Notified Body Kiwa Dare! for CE marking of medical devices conform the Medical Device Regulation (MDR) as certified lead auditor, product reviewer and application reviewer & for ISO certification of Quality Management System conform EN-ISO 13485 as certified lead auditor and application reviewer

• At various medical device companies in Quality Assurance & Regulatory Affairs functions

• Proven market access in the following regions: Europe, North-America, Asia, Australia, Middle-East, Africa and Latin America 

• Setting up Quality Management System conform MDR 2017/745, IVDR 2017/746, the latest version of the MDCGs, the latest version of the EN-ISO 13485, the latest version of the EN-ISO 27001 and 21 CFR 820

• Participation NEN Expert Group ‘Artificial Intelligence & Medical Devices’

• Acting as trainer for Mikrocentrum for various courses

• Different product types and classifications
  • Active and Non-Active (sterile and non-sterile) medical devices
  • Invasive and Non-invasive medical devices
  • (Active) Implantable Medical Devices
  • Class IIb, Class IIa, Class Is, Class Ir & Im Medical devices
  • Class A, B and C (In Vitro Diagnostic Medical Devices)
  • Class A, B and C software medical devices

Experience with various eQMS systems, e.g. but not limited to: Greenlight Guru, Scilife, Bizzmine, Zenya and Matrix Requirements.

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