Service MedtecLIVE 2024

Regulatory Affairs

Benefit from the extensive and long-standing experience of our experts: We accompany the entire process, from consulting to approval requirements, standard-compliant development and production through to the certification of medical devices.

  • Regulatory Affairs: standard-compliant through approval
    Regulatory Affairs: standard-compliant through approval
  • Quality management in accordance with current norms and standards
    Quality management in accordance with current norms and standards

Benefit from the extensive and long-standing experience of our experts:

  • Consulting, concept development and implementation support
  • Quality and risk management
  • CE and FDA-compliant documentation
  • CE conformity assessment
  • Support for CB type testing
  • Regulatory support in accordance with MDR and CFR820
  • Standard-compliant design transfer and product launch

Get more information about Regulatory Affairs here.

Our brochure is available for download.

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