Tailored support to secure UKCA or CE-marking for your medical devices.
Taking the complexity out of medical device compliance
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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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From Idea to Approval: Get MDR Ready With Our LinkedIn Live
An upcoming LinkedIn Live session with Dr. Zhong Wei Khor tailored specifically for healthtech founders.
Dr Paul Hercock
Chief Executive Officer
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The Never-Ending Document Updates: Navigating Changing Regulations
Just because you’ve submitted a document, it doesn’t mean the work is done. Clinical Evaluation Reports, Risk Management Files or PMS plans will all need updating.
Kamiya Crabtree
Regulatory Medical Writer
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Going Global, Staying Grounded: Mantra Systems Moves to .com
What began as a small consultancy in Sheffield has grown into a trusted partner in the medical device industry. Now we've made a change that reflects our international reach.
Shona Richardson PhD
Regulatory Project Lead
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UK Medical Device Regulations Set for Major 2026 Update
The UK government is preparing to introduce a second major update to the regulatory framework for medical devices, with new pre-market requirements expected to come into effect in 2026.
Dr Simon Cumiskey
Senior Lead Medical Writer
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SOTA Exclusions: The Ongoing Quest for Clarity
SOTA exclusions aren’t just a box-ticking exercise, they’re a true test of your reasoning and your ability to defend your choices with confidence.
Kamiya Crabtree
Regulatory Medical Writer
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Clinical Evaluation Masterclass: It is not clear that any systematic search methods were used for the literature review – Episode 3
Addressing non-conformities isn’t just about avoiding negative outcomes; it’s about building a robust, evidence-based foundation.
Dr Paul Hercock
Chief Executive Officer
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