About ZYK.

Dietmar Schaffarczyk

Position: Lecturer, Lead Auditor, Senior Certification Expert, CEO / Managing Partner

Professional Summary:

Highly accomplished professional with extensive experience in Regulatory Affairs and Certification / Reimbursement Services within the healthtech industries. Expert in training, implementation, and auditing of various regulatory standards. Renowned for substantial contributions in medical device and biotech industries, including being an award-winning CEO and keynote speaker.

Key Expertise:

• Regulatory Compliance (21 CFR 820, MDSAP, ISO 13485, GMP, GLP, GCP, ICH)
• Technical Documentation Assessment (MDR/IVDR/510k/De Novo/DiGA)
• Risk Management (ISO 14971)
• Usability Files (ISO 62366)
• Biological and Clinical Evaluation / PMS 
• Reimbursement: DiGA, GKV
• Familiarity with MDD, MDR, IVDR, and various EU regulations
• Expert witness in legal disputes related to medical and biotech fields

Professional Experience:

• Lead QM Auditor and Technical Assessor: Medtech / IVD / BioTech
• Conducted comprehensive audits and technical assessments
• Developed certification strategies and QARA systems for international companies
• Senior Certification Expert
• Led teams in implementing quality and transparency standards
• CEO / Managing Partner
• Oversaw operations in medical device and biotech companies
• Received numerous awards for innovation and leadership
• Lecturer, ETH Zurich & Other Institutions
• Taught courses in Regulatory Affairs and Quality Assurance
• Specialized in clear, effective communication of complex information
• Initiator of the RegulatoryThinking approach in heathtech industries