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Regulatory Affairs

Planning and Testing from a Single Source

Mechanical Safety and Clinical Performance -

are among the basic requirements for a successful approval of a medical device.

 

Our experienced interdisciplinary Regulatory Affairs Team supports you in the following areas:

 

Mechanical testing – planning and evaluation:

  • Literature-based derivation of the mechanical requirements that an implant as to fulfill
  • Definition of acceptance criteria for mechanical testing
  • Derivation of worst case sizes for mechanical testing
  • Evaluation of the test results

 

Technical Documentation:

  • Preparation of a Clinical Evaluation according to MEDDEV 2.7/ Rev. 4
  • Proof of compliance with the Essential Requirements (Annex I, Directive 93/42/EEC)
  • Preparation of risk analyses according to DIN EN ISO 14971 (FMEA)
  • Risk classification according to Annex IX of Directive 93/42/EEC