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REGULATORY AFFAIRS

Planning and Testing from a Single Source

Regulatory Affairs Services

Mechanical safety and clinical performance are among the basic requirements that a medical device must meet for successful approval.

 

Our experienced interdisciplinary Regulatory Affairs team will support you in the following areas:

 

Mechanical Testing - Planning and Evaluation

  • Literature-based derivation of the mechanical requirements for an implant
  • Definition of acceptance values for mechanical testing
  • Derivation of worst case values 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