Randolph Stender, Dipl.-Ing.

Randolph Stender has over 20 years of experience in the medical device industry, including 16 years as a managing consultant and lead auditor for international medical device companies. He supports clients worldwide with the optimum management of complex projects as well as interim management.

Randolph holds a university diploma in clinical technology and is an active member of the committees ISO TC 210/WG1 (which manages ISO 13485), TC210/JWG1 (which manages ISO 14971), and various other national and international committees and associations.

Randolph is the author of a specialist book on quality management (in German) titled “Qualitätsmanagement für Hersteller von Medizinprodukten (Beuth-Verlag),” and he has published numerous technical articles and expert reports. He is a speaker and trainer for NSF’s Medical Device Academy as well as many other organizations on a range of regulatory topics.

Areas of Expertise:

• Project and Interim Management
• Regulatory Affairs
• Risk Management Systems
• Quality Management Systems
• Medical Device Software
• Usability and Human Factors
• Process Control and Validation
• Audits and Inspections
• Speaker at Conferences
• Training Instructor