Tailored support to secure UKCA or CE-marking for your medical devices.
Taking the complexity out of medical device compliance
Learn how
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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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Webinar: Regulatory Strategy Essentials for Digital Health
We show how you can accelerate your runway to market through 5 actionable steps that will shave months off your route to regulatory approval.
Dr Peter Boxall
Lead Medical Writer
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Vigilance & Incident Reporting: Everything You Need to Know
Navigating the Complexities and Ensuring Patient Safety in Medical Devices.
Gabriela Cardoso
Regulatory Medical Writer
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Achieving EU MDR approval when you are approved under FDA
Our guide to navigating the transition from FDA approval to EU market access.
Chandini Valiya Kizhakkeveetil
Regulatory Medical Writer
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Post-Market Surveillance (PMS): Understanding PMCF & Vigilance under the EU MDR
These serve distinct purposes and have different methodologies under the MDR framework. We breakdown each.
Ronghe Xu
Regulatory Medical Writer
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Implementing Master UDI-DIs: Key Insights from MDCG 2025-7
Grouping devices with design similarities under a common Eudamed ID could unify them under a single master UDI-DI
Dr Will Brambley
Lead Medical Writer
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In the World of Regulatory Writing: 5 Lessons Learned
Let’s break down some key lessons learned from the writing process and share practical tips to navigate them with clarity (and your sanity) intact.
Kamiya Crabtree
Regulatory Medical Writer
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