Medical Devices
Medical Devices

Medical devices and In vitro Diagnostic

The European regulatory landscape for medical devices has been increasing in complexity, creating greater challenges that demand an immediate solution to maintain or gain access to the European markets. BCCC collaborates with MedTech companies, providing guidance on navigating the regulatory landscape to ensure the placement and maintenance of medical devices and in vitro diagnostics in the EU market through the following Regulatory Services.:

  • Support in preparing technical documentation and post-market technical documentation.
  • Developing a roadmap for CE marking and regulatory strategy.
  • Creating and conducting clinical evaluation and performance evaluation processes.
  • Facilitating communication with notified bodies, competent authorities, and economic operators.
  • Assisting in the transition to MDR/IVDR
Contact with us

Do not hesitate to contact us for any information or details of our CRO.

On Wednesday, June 7, a meeting of researchers from the iliCo study was held in Leipzig, as part of LINC 2023

Món Clínic is taking part in Scientific Advices provided by the experts panel in the pilot test opened by the EMA (European Medicines Agency) to manufacturers of certain high-risk medical devices, with the aim of guiding and helping them on their intended clinical development strategies and proposals for clinical investigations