Achieve medical device regulatory approval for UKCA & CE-marking.
Medical Device Regulatory Consulting
We help manufacturers around the world achieve UKCA & CE-marking for their medical devices
Our Clients say
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Not only were 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.
Courtney Regulatory Affairs Manager Northgate Technologies
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Their commitment to delivering high-quality literature papers is evident and I look forward to working together again in the future.
Ambal Engineering Quality & Regulatory Manager LifeSignals
Our Clients
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.
Our Clients say
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Mantra Systems have provided outstanding quality SOTAs for our medical devices.
Trevor Principal Scientist Procter & Gamble
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Mantra Systems' documentation was approved by our Notified Body on the first review.
Andrea Compliance Director Cardioline
Resources for Medical Device Regulation
Get guidance on medical device regulation through exclusive resources written by our subject matter experts
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EU MDR Compliance Guide
A free Medical Device Regulation guide
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MDR & MDCG Chatbot
AI-powered MDR & MDCG chatbot
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White Papers & Guides
Free MDR & IVDR White Papers & Guides
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Online Training Courses
Drive your own regulatory strategy
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Document Templates
Build your medical device technical file
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Articles & News
Analysis from our medical writers
Free MDR Compliance Checker Evaluate your regulatory strategy against EU MDR requirements for all your medical devices
Latest articles
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IEC 62366-1:2015 Demystified – Essential Usability Testing for Medical Devices
What should be included in a Usability Engineering File? What steps do you need to take to ensure compliance and meet standards?
Kamiya Crabtree
Regulatory Medical Writer
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Unlocking the Secrets of Effective IVD Device Performance Evaluation
Whether preparing for a new EU market submission or strengthening existing documentation, this guide is your overview of performance evaluation under IVDR.
Kamiya Crabtree
Regulatory Medical Writer
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Clinical Evaluation Masterclass: Appraisal of literature sources has not been conducted properly - Episode 2
Our ongoing series covers one of the most frequent reasons for CER rejection: a poor appraisal of literature sources.
Dr Paul Hercock
Chief Executive Officer
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Navigating CAPA Terminology: Key Terms for Medical Device Professionals
We define and explain the language required to work within a Quality Management System (QMS).
Kamiya Crabtree
Regulatory Medical Writer
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Clinical Evaluation Masterclass: Overcoming Non-conformities - Episode 1
In this series, we work step-by-step through common Non-Conformities to ensure you are always ahead of possible challenges on the way to MDR approval.
Dr Paul Hercock
Chief Executive Officer
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MDCG 2020-16 Revision 4: Key Updates on IVDR Classification Rules
We detail how this revision ensures manufacturers, notified bodies, and health institutions have a clearer regulatory framework.
Chandini Valiya Kizhakkeveetil
Regulatory Medical Writer
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