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
Free MDR Compliance Checker Evaluate your regulatory strategy against EU MDR requirements for all your medical devices
Latest articles
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EU MDR, FDA 510(k) and DTAC Cybersecurity Nonconformities: How to Recover
This guest article shows how these cybersecurity nonconformities happen, what recovery actually involves, and what to build so you don't go back.
Neil Richardson
Co-Founder of Cyber Alchemy
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How to handle non-conformities and get back on track
A practical guide to understanding why non-conformities happen, the most common issues in medical device submissions, and how to resolve them efficiently to get you back on track.
Dr Will Brambley
Lead Medical Writer
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Clinical Evidence under EU MDR: Leveraging FDA Clinical Data to Streamline EU MDR Compliance
FDA approval alone is not sufficient for European market access - a theme we explore futher in this article and the accompanying webinar.
Chandini Valiya Kizhakkeveetil
Regulatory Medical Writer
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EU MDR & NHS DTAC Cybersecurity Requirements for UK Market Entry
This guest article shows you how to build cybersecurity evidence for the EU MDR and NHS DTAC.
Luke Hill
Co-Founder of Cyber Alchemy
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Where to Launch First? A MedTech Founder's Regulatory Roadmap to the EU, UK and US
All three markets operate under different regulatory systems and place different demands on manufacturers.
Ronghe Xu
Regulatory Medical Writer & Strategic BD Lead China
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Navigating EU MDR Article 117: A Practical Guide to Drug-Device Combination Product Submissions
Implementation of the EU MDR 2017/745 has brought significant changes.
Chandini Valiya Kizhakkeveetil
Regulatory Medical Writer
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