Regulatory Affairs

Regulatory Affairs - secure for global product approval of medical devices


There are a wide variety of requirements for the registration and approval of medical devices, combination products and in-vitro diagnostics (IVD) worldwide. Standards, regulations and norms are continuously updated, requirements increased or redefined. The medical technology industry must keep pace with these requirements in order to ensure its business activities are sustainable. The smooth handling of the approval processes plays a decisive role in this.


There are a wide variety of requirements for the registration and approval of medical devices, combination products and in-vitro diagnostics (IVD) worldwide. Standards, regulations and norms are continuously updated, requirements increased or redefined. The medical technology industry must keep pace with these requirements in order to ensure its business activities are sustainable. The smooth handling of the approval processes plays a decisive role in this.

There are a wide variety of requirements for the registration and approval of medical devices, combination products and in-vitro diagnostics (IVD) worldwide. Standards, regulations and norms are continuously updated, requirements increased or redefined. The medical technology industry must keep pace with these requirements in order to ensure its business activities are sustainable. The smooth handling of the approval processes plays a decisive role in this.



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