Ulrich Schwanke is a licensed medical doctor and certified Lead Auditor for DIN EN ISO 13485. His career began in clinical practice — with a focus on patients, diagnoses, and treatment outcomes. He brings this medical foundation directly into his regulatory work: he doesn't just assess medical devices formally, he understands how they perform in everyday clinical reality.
With more than 20 years of experience and over 100 completed projects in the healthcare sector, Ulrich Schwanke guides companies through the CE marking process under MDR 2017/745 — from classification and regulatory strategy through technical documentation to clinical evaluation (CER). 

His consulting portfolio covers the design and certification of quality management systems under ISO 13485, risk management under ISO 14971, process qualifications (IQ/OQ/PQ), and post-market surveillance including PMCF. He conducts internal audits and supports companies through surveillance audits by Notified Bodies as well as FDA inspections. When staffing gaps arise, he steps in as interim QMB (Quality Management Representative) or interim Head of Regulatory Affairs.

He is particularly valued as a trusted partner for start-ups and small to mid-sized medical device companies — a pragmatic problem-solver who cuts through complexity without compromising regulatory quality. He is currently advising companies on the use of artificial intelligence and large language models (LLMs) in medical devices, a field where early clinical expertise and regulatory knowledge are equally essential.

Ulrich Schwanke is based in Langenfeld, Germany, and works nationwide as well as remotely.