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