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Mastering the MDR White Paper
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A summary of the MDR (EU) 2017/745 which highlights areas in the text most relevant to medical device manufacturers.
Files included
Mastering the MDR White Paper Edition 4.1.pdf
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Choose from our range of professional resources and use your existing product knowledge to build your medical device technical files
Regulatory Templates
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Free CER Template
Complete Clinical Evaluation Reports for any class of medical device using our proven CER structure.
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Free MDR Compliance Checker
This unique MDR Compliance Checker walks you through technical file requirements line-by-line, enabling you to comprehensively check your compliance using no more than simple yes / no questions.
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MDR Annex II Templates
The comprehensive solution to producing EU MDR Annex II technical documents for your medical devices.
- £295
Risk Management Templates
Build an adaptive & ISO 14971:2019-compliant Risk Management system for all your medical devices.
- £595
Clinical Evaluation Plan CEP Template
Produce Clinical Evaluation Plans for any class of medical device using a proven structure designed by experts.
- £795
Full Clinical Evaluation Report CER Template
Produce Clinical Evaluation Reports for any class of medical device using a proven start-to-finish methodology.
Regulatory Courses
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MDR CER Writing
Learn the secrets of our successful Clinical Evaluation process and become a confident writer of CERs for your medical devices.
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Understanding the EU MDR
Gain clarity & context on overall EU MDR requirements for your entire medical device regulatory strategy.
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Risk Management Systems
Develop the capability to build, document & maintain an ISO 14971:2019-compliant Risk Management system.
White Papers
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Mastering the MDR White Paper
A summary of the MDR (EU) 2017/745 which highlights areas in the text most relevant to medical device manufacturers.
- Free email delivery
PMS in the MDR White Paper
Get free guidance on system design, implementation and reporting for Post-Market Surveillance in the MDR.
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Software as a Medical Device White Paper
Learn whether or not the MDR will apply to your software medical device and how to work with the new legislation.
Guides
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MDReady Starter Guide
Our free step-by-step guide is the start of your journey to EU MDR compliance.
Bundles
- £445
Risk Management Plus
Reduced price bundle includes Risk Management Templates & Risk Management Training Course.
- £595
Technical Documents Master
Reduced price bundle includes Annex II Templates, Risk Management Templates & Risk Management Training Course.
- £1,095
Clinical Evaluation Premium
Reduced price bundle includes CER Template, CEP Template & MDR CER Writing Training Course.
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Medical Minds for Market Access
Services
Expert MDR & IVDR Consultants
Mantra Systems provides professional MDR & IVDR consulting services to companies seeking compliance & market access for any class of medical device.
Resources
EU MDR Compliance Guide
Our free EU MDR Compliance Guide covers 24 topics relating to Medical Device Regulation. It's a great starting point to help direct your regulatory strategy.
Resources
Articles, News & Industry Analysis
Read our analysis and get guidance on medical device regulatory requirements including our observations on developments in the industry.
Any questions?
If you have any questions about our resources or would like a free & confidential discussion about your medical device, we'd love to hear from you.