CE Certification & Technical File

Classification, CE marking, technical documentation. We have the expertise and competent professionals for all aspects of regulatory and market-related issues. Opera can support most manufacturers of Medical Devices (MD), combination products, and In Vitro Diagnostics (IVD), to get your product to the market and keep it there.

We welcome any questions that arise with regard to market requirements, medical devices directives and notably the new EU regulations on medical devices.

Key activities:

  • Confirm Medical Device Status and Class

  • Identify and Meet Essential Requirements

  • Technical Documentation

  • Conformity Assessment