Regulation (EU) 2024/1860 - Its impact on EU MDR and IVDR
How does the recent Regulation (EU) 2024/1860 amendment affect the EU MDR & IVDR?
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Mantra Systems have provided outstanding quality literature search reports and State of the Art appraisals for our medical devices; I would thoroughly recommend them.
TDDr. Trevor Day Principal Scientist Procter & Gamble
Mantra Systems' expertise, attention to detail towards appropriate literature papers, and dedication to accuracy have truly made a difference. Their commitment to delivering high-quality work is evident and I look forward to the possibility of working together again in the future.
AAmbal Engineering Quality & Regulatory Manager LifeSignals
We serve an international client-base covering all classes of medical device across a wide range of clinical fields.
Our clients are based around the world, hailing from the UK, Europe, North America, Central America, Asia and the Middle East, and vary in size from pre-market start-ups to stockmarket-listed multinationals.
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Mantra Systems authored an excellent and thorough Clinical Evaluation Report (CER) for our medical device, according to both UK & EU MDR, which was delivered on time. I was highly impressed by their expertise and professionalism throughout and wouldn't hesitate to work with them again.
MHMonica Hodgkinson Regulatory Compliance Manager GV Health Ltd
Not only was Mantra Systems very easy to work with, but their clinical knowledge and dedication to helping us meet the tight timelines for response was top notch. We have worked with other consultants in the past, but we were never satisfied with the output. Other companies required us to put in a lot of extra labor to format and sometimes redo what was provided – that is not the case with Mantra Systems. We hope to have another opportunity to work with them.
CCCourtney Civik Regulatory Affairs Manager Northgate Technologies Inc.
How does the recent Regulation (EU) 2024/1860 amendment affect the EU MDR & IVDR?
How to apply MDR pre-market clinical evidence requirements to medical devices intended for limited usage.
How do you define intended purpose, indication for use, intended clinical benefits, and claims?
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