The collaborative & transparent route to guaranteed MDR / IVDR compliance
Not only was 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
Accelerate market traction through forward-thinking consulting services
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.
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
Get guidance on medical device regulation through exclusive resources written by our subject matter experts
A free Medical Device Regulation guide
AI-powered MDR & MDCG chatbot
Free MDR & IVDR White Papers & Guides
Drive your own regulatory strategy
Build your medical device technical file
Analysis from our medical writers
The EU and the MHRA have extended the validity of IVDD certificates, allowing you more time to transition to the IVDR. We explain what this means for manufacturers.
Kamiya Crabtree
Regulatory Medical Writer
This regulation emphasizes risk management, durable design & biocompatibility to ensure medical devices are safe and effective. GSPR 1 protects users while driving innovation in medical technology.
Kamiya Crabtree
Regulatory Medical Writer
Patients can be exposed to risks when devices are online. We explore implications for EU MDR/IVDR cybersecurity requirements, including MDCG guidance
Dr Clare Dixon
Regulatory Specialist
The Unique Device Identifier (UDI) ensures medical device traceability and compliance. We break down its structure, Device Identifier (UDI-DI), Production Identifier (UDI-PI) and its role in EUDAMED.
Kamiya Crabtree
Regulatory Medical Writer
The transition from IVDD replaces list-based classification with a risk-based approach. Manufacturers must thoroughly understand the rules outlined in Annex VIII of the IVDR.
Dr Gayle Buchel
Chief Medical Writer
Good Machine Learning Practice (GMLP) principles ensure safe devices, covering intended use, clinical evaluation & Human-AI Interaction (HAII).
Ron Sangal
Lead Medical Writer
Whatever you need, contact us today to start your free, no-obligation consultation.
We respect your information — Read what this means