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About the channel
Mantra Systems is a collaborative medical device consulting company. We specialise in obtaining regulatory approval for medical devices under UK & EU MDR and IVDR, and offer additional market access services geared towards product approval and adoption. Our expertise has expanded our clients’ potential through forward-thinking EU/UK MDR, IVDR & FDA services for both physical & software medical devices. With deep industry knowledge and experience, we personalise every client’s project, which provides transparency and guarantees value.
Latest videos
IVD Approval Taking Too Long? Start With Your Performance Evaluation Plan
9 views · 07/24/2026
The Slowdown 5 - Five Critical Mistakes That Are Seriously Delaying Your SaMD Market Entry
14 views · 07/17/2026
Stop Recertifying Every SaMD Update | PCCP Explained
14 views · 07/10/2026
Why Notified Bodies Reject PMCF Surveys (And How to Fix Yours)
20 views · 07/03/2026
What is PMCF? Post-Market Clinical Follow-Up Under EU MDR Explained
37 views · 06/26/2026
Free EU MDR Compliance Plan for US medical device manufacturers
29 views · 06/19/2026
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