How to achieve MDR Compliance for Class I medical devices
We outline a strategy for the regulatory compliance of Class I medical devices.
Sandra Gopinath
Articles & News
Expert analysis on medical device regulatory requirements
Latest articles
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Sandra Gopinath
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Systematic Literature Review & Clinical Evaluation
We help to demystify the process of systematic review of literature for Clinical Evaluation.
Sandra Gopinath
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Literature Reviews for medical devices - what to know before you start
We explain what you should know before beginning a Systematic Literature Review for your medical device.
Sandra Gopinath
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Five useful resources when writing a medical device CER
We outline five of the most useful and trustworthy Clinical Evaluation Report writing resources.
Dr Victoria Cartwright
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Five common pitfalls when writing a Clinical Evaluation Report
We illustrate five pitfalls when writing CERs and give you some tips to overcome them.
Dr Paul Hercock
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Five tips for making a medical device equivalence claim under the MDR
We'll show you what to keep in mind with regards to equivalance and Clinical Evaluation.
Sandra Gopinath
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Keeping medical devices in market & maintaining CE-marks
The 4 golden rules to drive regulatory compliance with PMCF and vigilance data collection.
Dr Paul Hercock
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How PMCF goes beyond simple compliance
The wider benefits of a well-designed PMCF system include improving your products and your relationship with your clients.
Dr Paul Hercock
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Why you'll almost certainly need a PMCF system for your medical devices
We tell you what to be aware of under the EU MDR regarding PMCF and your medical devices.
Dr Paul Hercock
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Build a winning EU MDR strategy for your medical devices
Watch our CEO, Dr Paul Hercock, deliver a Mantra Systems webinar on MDR compliance strategy.
Richard Jones
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Does my medical device need a PMCF system for MDR compliance?
Answer 10 quick questions to check whether your medical device requires a PMCF system.
Matthew Stinson
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The impact of Brexit on medical device regulatory compliance
How to ensure regulatory alignment of your devices in the territories affected by Brexit.
Dr Paul Hercock
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Is outside consulting support the answer to your MDR transition?
Getting ready for the MDR is a demanding process. Outsourcing might be your solution.
Dr Paul Hercock
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Increasing data entry compliance in PMCF studies
5 methods every medical device manufacturer should know to improve their Post-Market Clinical Follow-up studies.
Dr Paul Hercock
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Simplifying the challenges posed by the new EU MDR
Our CEO Dr Paul Hercock was invited to speak on a Kaizen Life Sciences podcast about the challenges posed by the EU MDR.
Dr Victoria Cartwright
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Why medical doctors can drive MDR compliance
Working with the MDR requires knowing how to work with clinical evidence. Medical doctors are perfectly positioned to meet this requirement.
Dr Victoria Cartwright
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Software as a Medical Device
Unless you have spent time working with medical device legislation in the past, the idea that software could be a medical device may be rather unexpected.
Dr Paul Hercock
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Ensuring that clinical investigations work in practice
How can medical device manufacturers ensure valid clinical investigations when access to medical expertise remains limited?
Dr Paul Hercock
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Relaxing medical device regulatory requirements during a healthcare crisis
During the coronavirus pandemic, how far should we go when relaxing medical device regulatory requirements?
Dr Paul Hercock
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A proposal to delay the EU MDR gets approved
A vote in the European Parliament has decisively approved a delay to full implementation of the EU's MDR by one year, allowing the medical device industry to prioritise its Covid-19 response efforts.
Richard Jones
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EU regulators may delay MDR enforcement. Out of the woods?
A delay of the MDR would be welcome news for many, but what would a delay mean in practice? To what extent can preparations for EU MDR be put on ice?
Dr Paul Hercock
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The new MDR compliance challenge
Across the industry, medical device companies are facing challenges in meeting the demands of the new Medical Device Regulations (MDR) 2017/745 framework.
Dr Paul Hercock
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Sources of Real World Evidence for MDR compliance
At Mantra Systems our objective is to make sure that our clients choose the method of real world data harvesting that is right for them.
Dr Paul Hercock