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Medical Devices and IVD Devices

Biomapas provides full scope regulatory affairs services for Medical Devices and In Vitro Diagnostic Devices according to EU MDR 2017/745 & 746.

We help operate in the complex field of scientific and regulatory requirements and provide high-quality services for your products’ clinical development from design, certification, and post-approval needs. As clinical experts, we provide you with focus and help you set realistic milestones, identify and mitigate risks, and align your goals with Notified Bodies’ requirements in the EU and EAEU.

This includes:

  • Guidance on medical device classification;
  • Consulting on the European Medical Devices Directives;
  • Clinical Evaluation of Medical Devices;
  • CE Marking Consulting for Medical Devices and IVDs;
  • Technical File Preparation for Medical Devices and IVDs;
  • Interaction with and documentation preparation for Competent Authorities;
  • Clinical Evaluation Reports for Medical Devices;
  • Authorized Representative service in EAEU.

Biomapas also offers Clinical Evaluation and Materiovigilance services on Medical Devices.