Thorsten Stumpf is an expert in medical device software – including cybersecurity and AI –, EU regulatory approval and international market access. His work includes, among others, the preparation of risk management files in accordance with ISO 14971, software development files in accordance with IEC 62304 and usability engineering files in accordance with IEC 62366-1, supporting manufacturers from intended use definition and requirements analysis through to regulatory approval. He also advises clients on strategic regulatory matters. His scientific academic background is complemented by extensive hands-on experience in regulatory submissions, verification and validation of medical devices, as well as certifications as RAC Devices Holder and Regulatory Affairs Manager International. Thorsten Stumpf is a speaker at professional conferences (including RAPS Euro Convergence) and trade fairs (including MEDICA).
Blog Post by Thorsten Stumpf - Project Lead Regulatory Affairs & TechDoc | RAC Devices
