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Medical Device Regulation Resources
Our Medical Device Regulation Resources contain information and guidance on a wide range of aspects across the regulatory landscape.
For further guidance or any specific enquiries, please contact our specialist consultants.
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EU MDR Compliance Guide
A free Medical Device Regulation guide
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EnableChat
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
Learn how to drive your regulatory strategy
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Document Templates
Build your regulatory compliant technical file
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Articles & News
Analysis from our medical writers
Latest articles
Stay informed with our industry-focused publications. You can also follow our updates on LinkedIn & YouTube.
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Regulation (EU) 2024/1860 - Its impact on EU MDR and IVDR
How does the recent Regulation (EU) 2024/1860 amendment affect the EU MDR & IVDR?
Shona Richardson
Regulatory Medical Writer
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MDCG 2024-10 - Orphan medical devices
How to apply MDR pre-market clinical evidence requirements to medical devices intended for limited usage.
Dr Simon Cumiskey
Lead Medical Writer
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A medical device's intended purpose - what is the point?
How do you define intended purpose, indication for use, intended clinical benefits, and claims?
Dr Simon Cumiskey
Lead Medical Writer
Expert MDR & IVDR Regulatory Consultants
Mantra Systems provides full MDR & IVDR consulting services to companies worldwide seeking UK / EU market access for any class of medical device.
Our unique network of medically-trained consultants will bring specialised clinical evidence appraisal & analysis to your medical device regulation strategy.