MDR Downloads Suite
Download our exclusive MDR White Papers, templates, tools and guides
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Premium Template PDF Clinical Evaluation Report Template
Our Clinical Evaluation Report Template will enable you to produce EU MDR-compliant CERs for your entire medical device portfolio.
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Premium Tool XLSX MDR Gap Analyser
Our MDR Gap Analyser tool will enable you to objectively evaluate your regulatory strategy against MDR requirements.
Please note: Compatible with Microsoft Excel / 365
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Free Guide PDF MDReady Starter Guide
Whether you are new to working with the EU MDR, or just need a bit of extra support, our step-by-step MDReady Starter Guide will help you produce a full regulatory package for your medical devices.
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Free White Paper PDF Mastering the MDR
This 23-page White Paper summarises the MDR and makes its contents easy to digest. It is intended to highlight those areas in the text that are most relevant to medical device manufacturers.
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Free White Paper PDF PMS in the MDR
The MDR places a higher burden on manufacturers in many areas including Post-Market Surveillance system design, implementation and reporting. This 12-page White Paper offers guidance on the requirements for PMS in the MDR.
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Free White Paper PDF Software as a Medical Device
Understand when and why the MDR applies to medical software, a rapidly growing sector of the medical device market. Learn whether or not the MDR will apply to your software product and how to work with the new legislation.
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Free Tool XLSX GSPR Matcher
This tool will instantly navigate Annex I MDR, quickly showing you which GSPRs apply to your products without the need to manually search.
Please note: Compatible with Microsoft Excel / 365
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Free Brochure PDF Our Services Brochure
A handy, downloadable guide to our unique approach to medical device regulatory consulting. Learn about our range of services and the advantages of engaging our team of specially-trained medical experts for your MDR compliance requirements.
When we release new editions, we will send you emails allowing you to download them. If you do not want to receive these notifications, please unsubscribe and we will remove your details from our database. These downloads carry an Exclusive Copyright Licence and must not be shared or modified without the express permission of Mantra Systems Ltd.