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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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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Do you have the clinical evidence you need to support regulatory approval?
Sue Kemp makes the case for implementing clinical strategy from day one.
Dr Paul Hercock
Chief Executive Officer
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A New Era for NHS Innovation: ‘Innovator Passports’
A digital fast-track system aims to transform how new medical technologies are adopted across the NHS, cutting red tape and accelerating access to medtech.
Kamiya Crabtree
Regulatory Medical Writer
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Finding My Passion at the Intersection of Science, Regulation, and Medical Devices
Our Regulatory Project Lead, Shen, shares her journey from the lab bench at NIBSC to supporting medical device manufacturers at Mantra Systems.
Shen May Khoo
Regulatory Project Lead
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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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