Implement a future-proof Clinical Evaluation process across your entire medical device portfolio.
This section introduces key concepts and places clinical evaluation into context. It also outlines some common pitfalls and sets out how to avoid them. Following completion, you'll be ready to move on to a detailed consideration of each section of the CER.
This chapter provides a detailed consideration of each section of an MDR-compliant CER. Learn how to correctly structure a CER and understand exactly what to include in each section.
A guide to choosing and working with CER templates, including what to look for and which criteria to use in making a choice. This section also introduces the EnableCE CER Template.
Choose from our range of professional resources and use your existing product knowledge to build your medical device technical files
Services
Mantra Systems provides professional MDR & IVDR consulting services to companies seeking compliance & market access for any class of medical device.
Resources
Our free EU MDR Compliance Guide covers 24 topics relating to Medical Device Regulation. It's a great starting point to help direct your regulatory strategy.
Resources
Read our analysis and get guidance on medical device regulatory requirements including our observations on developments in the industry.
If you have any questions about our resources or would like a free & confidential discussion about your medical device, we'd love to hear from you.