Learn how to build a foundation for your entire EU MDR system.
This section lays the foundations for more detailed considerations which follow. It provides an overview of the EU MDR, its structure, and the main requirements it imposes on manufacturers. It also considers which types of products fall within its legislative reach.
Dig deeper into working with the MDR and build the basis for a successful strategy. Understand how to classify devices and perform a GSPR relevancy analysis, and gain further insight into requirements for placing devices on the market.
Gain an understanding of vital regulatory systems and processes: QMS, PMS and Risk Management.
A detailed consideration of clinical evaluation, writing a CER, and accessing support services for this challenging aspect of MDR compliance.
Understand how to form an overall assessment of your MDR strategy through structured Gap Analysis. Learn the importance of document management and gain insight into tools for organising and maintaining your MDR technical files.
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.