Tailored support to secure UKCA or CE-marking for your medical devices.
Taking the complexity out of medical device compliance
Learn how
or explore our consulting services…
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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Regulatory Reset? The EU’s Proposed Changes to MDR and IVDR Explained
Changes published in December 2025 aim to streamline EU medical device and in vitro diagnostics. We explain who is impacted and how.
Dr Gayle Buchel
Chief Medical Writer
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Did You Know Your Glasses Were a Medical Device? A Regulatory Guide for Manufacturers
The importance of correct classification and our recommended path to avoid common ophthalmic device 'gotchas'.
Gabriela Cardoso
Regulatory Medical Writer
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Why Clinical Trial Design Should Begin at the Earliest Stages of Medical Device Development
In this guest post from our partners at Franklyn Health, they explore the benefits of a well-planned approach.
Rob Bedford
Head of Clinical Operations at Franklyn Health
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The Shift from MDD to MDR: Key Differences in Demonstrating Equivalence
This transition has demanded that device safety must be demonstrated with more evidence. We offer tips for winning equivalence claims.
Kamiya Crabtree
Regulatory Medical Writer
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2025: A year in review
Our CEO takes a seasonal look back at our year in medical device regulation. Plus a peek at some of our offerings planned for 2026.
Dr Paul Hercock
Chief Executive Officer
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Periodic Safety Update Report: Requirements under EU MDR
Post-Market Surveillance has become more stringent. We help you to understand what manufacturers need to consider.
Chandini Valiya Kizhakkeveetil
Regulatory Medical Writer
Free AI-powered Regulatory Chatbot Ask our chatbot a question about the MDR & MDCG Guidelines. No sign-up — it's free
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