Meet Our Experts

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Experts for: Medical Devices

Anke Maaßen

Anke Maaßen

Expert for In Vitro Diagnostics (IVDs)

  • Regulatory Affairs (EU regulations: IVDD and IVDR)
  • Quality Management and Assurance
  • Internal and Supplier Audits
  • Support for Manufacturing and Control
Michael Zimmermann

Michael Zimmermann

  • Expert for conformity assessment according to Regulation (EU) 2017/745 (MDR)
  • Clinical investigations and clinical evaluations
  • PMCF
  • Technical documentation and Design Dossiers
  • Seminars and training courses on clinical investigations and clinical evaluations
Siglinde Dürr

Siglinde Dürr

Expert for Quality Assurance

  • Implementation of Quality Systems according to GMP, GCP or ISO regulations
  • Conduct quality audits (GMP/GCP/ISO)
  • Develop and implement Standard Operating Procedures
  • Project management of funded projects