Skip to main content
Hello, how can I help you?
Björn Spies, Mitarbeiter bei Inmedis

Björn Spies

+41 41 725 36 80
b.spies@inmedis.ch
vCard

Training

  • MSc in Electrical and Information Technology, Karlsruhe Institute of Technology
  • Advanced training courses in regulatory affairs, quality management and auditing, including courses with TÜV Süd and CQI IRCA

Work experience

Björn Spies has been working in MedTech and IVD since 2005. He initially worked as a development engineer and project manager at companies such as BrainLAB and QIAGEN, before moving into complaints management and project management at DePuy Synthes and Baumann Medical.

Since 2017, he has been a Senior Consultant at inmedis AG, supporting clients in regulatory affairs and quality management. During this time, he has assisted various companies with MDR preparation, the development of technical documentation, and the implementation and further development of quality management systems. He also provides support with audits, supplier management, vigilance systems and the validation of manufacturing processes.

Specialist knowledge

  • Regulatory Affairs and MDR 2017/745
  • Technical documentation and risk management in accordance with ISO 14971
  • Quality management systems and audits in accordance with ISO 13485 and MDSAP
  • Complaints management and vigilance systems (FDA 21 CFR 803)
  • Process validation and statistical process controls
Back to inmedis team