Tailored support to secure UKCA or CE-marking for your medical devices.
Taking the complexity out of medical device compliance
Contact us today
or explore our consulting services…
-
UK & EU MDR Consulting
-
Clinical Evaluation
CEP & CER writing services with success across 250+ submissions spanning all risk classes.
-
IVDR Consulting
Ensure your in vitro diagnostic medical devices gain first-time IVDR approval.
-
SaMD Accelerated Approval
Software as a Medical Device certification where time-to-market is existential.
-
US to EU Market Access
We'll leverage your device's existing FDA 510(k) clearance to accelerate UK & European certification.
-
QMS Jumpstart
An all-in-one Quality Management System platform will ensure you meet ISO 13485 requirements.
What Our Clients Say
-
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
-
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.
What Our Clients Say
-
Mantra Systems have provided outstanding quality SOTAs for our medical devices.
Trevor Principal Scientist Procter & Gamble
-
Mantra Systems' documentation was approved by our Notified Body on the first review.
Andrea Compliance Director Cardioline
Are you looking for…
- Expert Regulatory Consulting?
- A quote for our services?
- Help understanding your options?
Whatever you need, contact us today for a same-day quotation.
Free MDR Compliance Checker Evaluate your regulatory strategy against EU MDR requirements for all your medical devices
Latest Articles
-
Security Risk Controls in the Medical Device Technical File
How to present medical device security controls as reviewer-ready evidence that clears EU MDR, FDA 524B and NHS DTAC faster.
Luke Hill
Co-Founder of Cyber Alchemy
-
Understanding Risk Management for SaMD
Practical guidance on SaMD risk management under EU MDR — from component-level hazard identification to Post-Market Surveillance and ISO 14971 traceability.
Megan Allen
Regulatory Medical Writer
-
Performance Evaluation under IVDR: The critical challenge behind CE marking
Understand EU IVDR Performance Evaluation requirements and learn how to build a compliant, evidence-based Performance Evaluation Report.
Dr Gayle Buchel
Chief Medical Writer
-
Avoiding slow SaMD approval: A guide to faster market entry
Most SaMD developers make avoidable mistakes that add months to approval. Here's what they are and how to sidestep them.
Paul Hercock
CEO & Founder
-
Top 5 mistakes US manufacturers make when entering the EU market
Expanding into the EU market? Discover the five most common regulatory mistakes U.S. medical device manufacturers make — and how to avoid them.
Aastha Kothari
Regulatory Medical Writer
-
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