Inhouse Training

 

We provide inhouse training tailored to your Needs. 

Some examples:

  • Basics and case studies  of  ISO 13485 and ISO 9001

  • Case studies  EN ISO 13485:2016

  • Internal audits for auditors

  • MDSAP Audit

  • Registration and CE mark of medical devices under MDR and IVDR

  • Technical documentation  of medical devices

  • Case studies under MDR and IVDR

  • GMP requirements of the FDA in comparison to Europe

  • Registration of medical device in the USA

  • Submission of a  510(k) 

  • Risk management ISO 14971

  • Biocompatibility of Medical Devices EN ISO 10993-1

  • Clinical Evaluation of medical devices

  • Usability - ISO 62366 and Human Factor 

  • Sterilization of medical devices

Contact

Bellingswood Group GmbH

Thurgauerstrasse 117

8152 Glattpark - Zürich

Switzerland

​​

Tel: +41 79 85 84 825

info@bellingswood.com

Impressum

Datenschutz

© 2019 by Bellingswood Group GmbH