Dirk Mueller

WORK HISTORY

EDUCATION

ABOUT DIRK MUELLER

I started my career in nuclear physics - studying nuclear structure with cyclotrons. After 8 years as Clinical Scientist and 5 years as Team Lead for manufacturers of Class devices, I deeply understood the diagnostic workflows and life-saving and enhancing devices. Today, I secure them from cyber threats while ensuring MDR and FDA compliance. Medical device manufacturers face a difficult triangle: Meet IEC 81•••51/FDA cybersecurity requirements, maintain agile development, and achieve operational efficiency - all while your dev, risk and PMS teams lack dedicated security expertise.Most consultants understand IT security medical devices. Few understand both. Even fewer have actually developed, tested, and commercialized them. I integrate cybersecurity into the existing product lifecycle as a quality feature over the full lifecycle: Threat modeling and SBOM compliant with EU & FDA requirements Security risk management that accelerates regulatory submissions PMS that turns compliance into a competitive advantage\' You\'re developing or maintaining medical devices and need cybersecurity expertise? Send me a message here on LinkedIn. SaMD Bone software Cardiac implants & imaging Radiology Surgical biomaterials Drug delivery Combination products Patient monitoring ISO 13485 IEC 62304 ISO 14971 ANSI/AAMI SW96 IEC 81•••51 ISO 14155 IEC 62366 CSV (GAMP5: cat. 3, 4, 5) Certified Secure Software Lifecycle Professional (ISC2) Security Architect – Udacity NanoDegree ISO 27001 Lead Auditor - Prospective, multicenter IITs (Co)-author in 25 peer-reviewed publications ⏩ Radiology ⏩ Cardiology ⏩ Surgery ⏩ Nuclear physics SQL Server, PostgreSQL Advanced SQL querying: Ubuntu, Kali, Arch Linux bash- C#/.NET ASP.NET Python- Splunk (SIEM) Snort + Sguil/Suricata Wireshark & MBA in Medical Device & Healthcare Management Financial Engineering Financial Modeling ISC² Professional Member