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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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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The Critical Role of Pre-Submission Reviews in EU MDR Clinical Evaluations
Ensuring your CER is robust and aligned with current standards is critical. How much Clinical Evidence is enough?
Sandra Gopinath
Chief Regulatory Officer
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Webinar: Regulatory & Cybersecurity Essentials for medical device software and AI-enabled devices
We are co-hosting a webinar with our friends at Cyber Alchemy to help manufacturers navigate this constantly evolving landscape
Shen May Khoo
Regulatory Project Lead
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Redefining Care Through AI: Perspectives from the AI in Health Summit 2025
Conversations around AI in healthcare have evolved dramatically over the past few years. We found insight, debate and a healthy dose of cautious optimism at this summit.
Kamiya Crabtree
Regulatory Medical Writer
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Guide to Clinical Evaluation: The State-of-the-Art (SOTA) Literature Review
Part 3 - This is core of a sucessful submission. Will demystifies the process and explains how it supports clinical evaluation.
Dr Will Brambley
Lead Medical Writer
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Regulatory Update: EU Borderline & Classification Manual for medical devices v4
New examples sharpen the distinction between medical devices and other product categories, such as pharmacologically active substances and aesthetic-only products.
Chandini Valiya Kizhakkeveetil
Regulatory Medical Writer
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