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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Webinar: From USA to Europe - Accelerating Your Path to the Medical Device Market
Join us on the 9th December 2025 to learn how to quickly transform your U.S. regulatory work into a compliant EU MDR submission.
Chandini Valiya Kizhakkeveetil
Regulatory Medical Writer
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Device Modifications: When a Simple Change Becomes a Regulatory Nightmare
As regulatory consultants we understand how minor modifications to a device can often cause disproportionate disruption.
Kamiya Crabtree
Regulatory Medical Writer
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Webinar: Regulatory & Cybersecurity Essentials for medical device software and AI-enabled devices
Our webinar with Cyber Alchemy addressed bringing AI-enabled medical devices to market with both the right regulatory and cybersecurity foundations.
Shen May Khoo
Regulatory Project Lead
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Mantra Systems at MEDICA 2025
Mantra Systems is once again going to MEDICA, the largest medical trade fair in the world. We hope to see you there.
Megan Allen
Regulatory Medical Writer
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Leveraging Post-Market Surveillance Data for Continuous Improvement
PMS isn’t just about compliance, it’s an opportunity for improvement, enhance patient safety & innovate.
Shen May Khoo
Regulatory Project Lead
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Guide to Clinical Evaluation: CEP Strategy & CER Structure
Part 4 - We explore how these guide reviewers through the evidence that supports safey, performance, and conformity.
Dr Will Brambley
Lead Medical Writer
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