Giessen, Hesse, Germany
Founder of Otter Compliance, building a specialized platform for Regulatory Affairs, Cybersecurity and Compliance in MedTech, Digital Health and Healthcare. Freelance Consultant supporting regulated companies with MDR, IVDR, NIS-2, CRA, IEC 62304, IEC 81001-5-1, ISO 14971, ISO 13485, cybersecurity documentation, risk management and audit-ready compliance processes.
Development of IVDR Medical Devices Ensuring Software- and Security Development lifecycle Prepare Technical Documentation Product registration in EU, US (FDA) and MDSAP Countries Development of AI driven medical Software
consultancy in regulatory operations for medical device key parts: international regulatory affairs and research, submissions, qualification and classification of devices, borderline and substance based medical devices, preparation of technical documentation, communication with notified bodys.