Putting together an MDR technical file is far from easy. Have you included everything? Is there sufficient detail? How can you confirm that the file will meet all relevant requirements?
This unique MDR Compliance Checker walks you through technical file requirements line-by-line, enabling you to comprehensively check your compliance using no more than simple yes / no questions.
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.