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Regulatory Affairs

Regulatory Affairs - Planning and Testing from a Single Source

Mechanical Safety and Clinical Performance are the basic requirements that an implant must meet for a convincing Technical Documentation and thus for successful approval. A large number of standards, guidelines, regulations and laws must be followed. The new Regulation on Medical Devices (EU) 2017/745, for example, poses great challenges for manufacturers and Notified Bodies.

Over 10 years of experience in the field of implant testing and our direct connection to university research are ideal prerequisites for the preparation of Technical Documentation according to EU-MDR and for approval by the US FDA.

 

Our range of services includes in particular:

 

  • Preparation of the Clinical Evaluation according to MEDDEV 2.7/ Rev. 4 to proof the in vivo performance of your implant.
  • Building of a complete chain of arguments to place evidence of the mechanical safety of your implant.
  • Starting with the in vivo loading of the implant and the acceptance criteria derived thereof, an individual strategy for the validation and verification of your implant will be set up.
  • After the worst-case selection, the test plan is created according to which the mechanical tests are to be performed. You can also order these tests from Spineserv - Planning and testing from a single source for maximum time and cost effectiveness!
  • Based on the initially compiled in vivo loads and acceptance criteria, the test results are finally evaluated.

 

 

In addition, our team helps you with questions on other topics, such as:

 

  • Proof of compliance with 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