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