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

 

ZYK@RegulatoryThinking

ZYK@dTIP Baden (ETH)

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