Randolf Stender

Randolph Stender, Dipl.-Ing.

General Manager

Medical Devices and IVDs

Europe

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

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