Dr. Peter Wirthschaft

Dr. Peter Wirthschaft has more than 12 years of experience in R&D, product management, marketing, sales and regulatory affairs for in vitro diagnostic (IVD) medical devices.

Prior to joining NSF, he developed and operated IVD medical devices at Germany’s largest research and clinical centers for oncology. He also launched new diagnostic devices and software in the EMEA market as part of the clinical NGS portfolio of Siemens Healthineers. At NSF, Peter focuses on regulatory and clinical affairs as well as quality management for IVD medical devices.

Peter has broad expertise in U.S. and EU regulations as well as industry standards and has led various consulting projects and held interim positions at medical device and pharma companies.

Peter holds a Ph.D. in neuro-oncology from the University of Heidelberg. He is also a keynote speaker at international conferences and conducts training and workshops for medical device and pharma companies.

Peter shares his knowledge and expertise in keynotes and videos to support IVD and medical device manufacturers. For examples, see:

• IVDR Advice for Experienced Manufacturers
• Changing Requirements for Manufacturers Under IVDR

Areas of Expertise:

• In Vitro Diagnostics
• EU In Vitro Diagnostic Regulation (IVDR)
• Regulatory Affairs
• Clinical Affairs
• Quality Management Systems
• Project and Interim Management
• Speaker at Conferences
• Training Instructor