Lizette de Groot is an experienced expert in medical devices. She worked for more than 15 years in medical device industry.
Gained Experience
Notified Body
Certified Lead Auditor, Product Reviewer, and Application Reviewer for CE marking under MDR, and for EN-ISO 13485 QMS certification.
Product Portfolio
Active and non-active (sterile and non-sterile), invasive and non-invasive, and (active) implantable medical devices.
Device Classes
Class IIb, IIa, Is, Ir, Im medical devices, and Class A, B, C In-Vitro Diagnostic Devices
Member of the NEN Expert Group ‘Artificial Intelligence & Medical Devices’.
Global Market Access
Proven experience in Europe, North America, Asia, Australia, the Middle East, Africa, and Latin America
QMS Implementation
Set up QMS compliant with MDR 2017/745, IVDR 2017/746, latest MDCGs, EN-ISO 13485, EN-ISO 27001, and 21 CFR 820.
Let’s work together
Whether you’re just starting or scaling up, we’re here to help you take the next step. We offer real-world guidance, clear strategies, and support that actually makes a difference, no guesswork, no overwhelm.