Gert – QA/RA Manager

Gert is driven by a practical mindset and a passion for finding regulatory and quality solutions that actually work—for people and in real-life settings. With hands-on experience from both startups and large-scale medical device companies, he brings deep insight into every stage of product development and compliance.

Gert is equally comfortable doing the work himself or guiding others through it. He’s a natural teacher and coach, known for making complex requirements understandable and actionable across teams.

He holds expert-level knowledge of MDR 2017/745, IVDR 2017/746, ISO 13485:2016, ISO 14971:2019, ISO 19011:2018, and key MEDDEV guidelines including 2.12-1 rev. 8 (Vigilance) and 2.7/1 rev. 4 (Clinical Evaluation).

Outside of work, Gert is a skilled cook and spends his free time mountain biking near the family summerhouse—where he’s also often immersed in hands-on building or tech projects.