Guides
Informative, detailed, fully updated and downloadable guides to ensure compliance for MDR and IVDR within the EU. Additionally, a checklist is available to help identify potential gaps in your clinical evaluation documentation.
The Ultimate Clinical Data Evaluation Checklist
The definitive guide to identifying potential gaps in your clinical evaluation.
The EU In Vitro Diagnostic Regulation Handbook
A comprehensive reference resource for In Vitro Diagnostic Device manufacturers operating or selling devices in the EU.
The EU Medical Device Regulation Guidebook
Providng you with an overview of the requirements of MDR so you can demonstrate compliance confidently.