Services in the field of medical devices

Our services include:
Regulatory Affairs / Quality Management / Vigilance
  • Feasibility assessment, medical device classification
  • Compilation of technical documentation
  • Risk management in accordance with EN ISO 14971
  • Conformity assessment procedures
  • Set-up and implementation of quality management systems (ISO 13485)
  • Audits
  • Vigilance relating to medical devices
  • Control of the promotional material considering the legal framework
In addition: Dudler Pharma LLC can act in Switzerland as an authorised representative (CH-REP) for your devices.