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Expert analysis on medical device regulatory requirements

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  1. Achieving MDR Compliance for Class I medical devices

    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 Sandra Gopinath
  2. Systematic Literature Review and Clinical Evaluation

    Systematic Literature Review & Clinical Evaluation

    We help to demystify the process of systematic review of literature for Clinical Evaluation.

    Sandra Gopinath Sandra Gopinath
  3. Literature Reviews for medical devices and what to know before you start

    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 Sandra Gopinath
  4. Five useful resources when writing a medical device CER

    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 Dr Victoria Cartwright
  5. Avoid pitfalls when writing a Clinical Evaluation Report

    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 Dr Paul Hercock
  6. How to make a medical device equivalence claim under the MDR

    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 Sandra Gopinath
  7. Keeping medical devices in market and maintaining CE-marks - a guide to effective data collection

    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 Dr Paul Hercock
  8. How PMCF goes beyond simple compliance - improving products and engaging customers

    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 Dr Paul Hercock
  9. PMCF systems for medical devices

    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 Dr Paul Hercock
  10. MDR Compliance Webinar - A masterclass on building a winning EU MDR strategy for your medical devices

    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 Richard Jones
  11. Our online PMCF Checker shows if your medical device requires a PMCF system

    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 Matthew Stinson
  12. Ensure medical device regulatory compliance of your devices through Brexit

    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 Dr Paul Hercock
  13. Use medical device regulatory consulting services to supercharge your MDR transition

    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 Dr Paul Hercock
  14. Increasing data entry compliance in PMCF studies

    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 Dr Paul Hercock
  15. Simplifying the challenges posed by the new EU MDR

    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 Dr Victoria Cartwright
  16. Why medical doctors can drive MDR compliance

    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 Dr Victoria Cartwright
  17. Software as a Medical Device

    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 Dr Paul Hercock
  18. clinical investigator for pmcf eu mdr compliance

    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 Dr Paul Hercock
  19. Coronavirus and medical device regulations

    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 Dr Paul Hercock
  20. EU flag

    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 Richard Jones
  21. EU regulators may delay MDR enforcement

    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 Dr Paul Hercock
  22. The new MDR compliance challenge

    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 Dr Paul Hercock
  23. Sources of Real World Evidence for MDR compliance

    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 Dr Paul Hercock

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