Mantra Systems provides a full suite of MDR & IVDR consulting services to companies worldwide seeking access to EU & UK markets for any class of medical device.
Our medically-trained consultants & subject matter experts will bring specialised clinical evidence appraisal & analysis to your medical device regulation strategy.
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, UK Procter & Gamble
Our Medical Device Regulation Resources contain information and guidance on a wide range of subjects across the regulatory landscape.
For further guidance or any specific enquiries, please contact our specialist consultants.
A free Medical Device Regulation guide
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Free MDR & IVDR White Papers & Guides
Learn how to drive your regulatory strategy
Build your regulatory compliant technical file
Analysis from our medical writers
We'll help you overcome the key steps in medical device approval with complete confidence, ensuring market access for your devices in the UK & EU
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.
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, Worldwide LifeSignals
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 contractors in the past, and we were never satisfied with the output. The work that was completed always required us to put in a lot of extra labor to format and finalize (and sometimes completely redo) what was provided – that is not the case with Mantra Systems. We hope we have another opportunity to work with Mantra Systems again.
CCCourtney Civik Regulatory Affairs Manager, USA Northgate Technologies Inc.
Stay informed with our industry-focused publications. You can also follow our updates on LinkedIn & YouTube.
How does the recent Regulation (EU) 2024/1860 amendment affect the EU MDR & IVDR?
Shona Richardson
Regulatory Medical Writer
How to apply MDR pre-market clinical evidence requirements to medical devices intended for limited usage.
Dr Simon Cumiskey
Lead Medical Writer
How do you define intended purpose, indication for use, intended clinical benefits, and claims?
Dr Simon Cumiskey
Lead Medical Writer
Search the MDR and MDCG documents in seconds by asking EnableChat your questions.
Dr Simon Cumiskey
Lead Medical Writer
We discuss the pros and cons of existing adverse event databases for vigilance data searching.
Dr Simon Cumiskey
Lead Medical Writer
We explain what the SSCP is, when you'll need it and what its objectives are.
Sandra Gopinath
Chief Regulatory Officer
Justifying scientific validity is the first step in proving compliance with the IVDR.
Dr Gayle Buchel
Chief Medical Writer
Mantra Systems is going to MEDICA 2023, the largest medical trade fair in the world. We hope to see you there.
Shen May Khoo
Junior Regulatory Specialist
Understand what changes to your medical device are considered 'significant' under EU MDR (2017/745).
Shen May Khoo
Junior Regulatory Specialist
