Why medical doctors can drive MDR compliance

Why medical doctors can drive MDR compliance

It is easy to become overwhelmed while trying to piece together an MDR strategy so it’s really important to consider one central fact — working with the MDR is, in a large part, about knowing how to work with clinical evidence. Whether it’s generating, searching, reviewing, appraising, interpreting or reporting clinical data, medical evidence is at the heart of MDR compliance.

However, in the absence of a medical or scientific background, working with clinical evidence isn’t easy. With the increased complexities of the new EU MDR, medical device manufacturers need easy access to skilled professionals who are comfortable working with and generating clinical evidence.

Medical doctors are increasingly recognised as being perfectly positioned to meet this requirement. Doctors are trained to work with clinical evidence from the early stages of their career. Furthermore, in many cases they have worked as clinical investigators on medical studies, meaning that they are better qualified to drive compliance with clinical investigation data entry.

Medical doctors also have a thorough understanding of the conditions that medical devices address, and have general clinical training that enables them to put diseases and interventions into context. In turn, this means that doctors are able to advise on pertinent data-points that can extract maximum value from Post-Market Clinical Follow-up (PMCF) and other performance monitoring studies.

Another advantage of working with medical doctors for MDR compliance is that doctors are professionally trained to perform objective assessments of clinical information, resisting sources of bias. This professional objectivity is of huge value in meeting MDR requirements for performing clinical evaluation of medical devices. Engaging a suitably-trained medical doctor from outside your organisation demonstrates a commitment to regulatory objectivity that will be favourably viewed by Notified Bodies and other regulators.

Doctors are also of value when trying to address any gaps in a medical device’s clinical evidence portfolio. An expertly-performed systematic literature review helps ensure that no relevant data is overlooked, and can also help to minimise expenditure on clinical investigations to generate new clinical data.

In summary, doctors have much to offer in helping medical device companies meet MDR requirements. Whether you are looking to perform an MDR Gap Analysis, design PMCF studies, implement PMS systems, interpret vigilance data, undertake risk management activities or perform Clinical Evaluation, engaging a medical doctor can be hugely advantageous.

So how can you find medical doctors who are trained in MDR compliance? At Mantra Systems we have a dedicated team of expertly-trained doctors who are specialists in producing and maintaining MDR strategies. We hope to have the opportunity to work with you.

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Our clients come from across the industry and range from pre-start businesses to stockmarket-listed multinationals. We also have key strategic partners based in the UK and Denmark.

  • It was a pleasure working with you. We are completely satisfied with your service and look forward to working with you again.

    CEO, EU medical software company
  • Your service surpassed our expectations and added value across our organisation. We now feel much better placed to prepare for the MDR.

    Chief Executive, MedTech pre-start
  • A comprehensive, detailed and highly professional service.

    Regulatory Manager, UK device manufacturer
  • International

    We work with medical device manufacturers based in the UK, Europe, the US and Asia, developing MDR strategies for both physical devices and software as a medical device.

  • Diversified

    Working with us gives you access to our growing international team of MDR-trained healthcare professionals from a wide variety of clinical backgrounds.

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FAQs

We have compiled some of our frequently asked questions. If you'd like to know anything else about what we do, feel free to ask us a question.

  1. We can work with the majority of medical device manufacturers seeking compliance of their devices in accordance with Medical Device Regulation (EU) 2017/745, including both hardware and software devices. We also offer a free, no-obligation consultation, so please feel confident about discussing your requirements with a member of our team.

  2. No. We will work with you to produce systems and to support your EU MDR compliance, but we do not conduct research ourselves. We will provide tools for you to conduct your own Post-Market Surveillance. Our range of services are designed to assist you in this matter.

  3. Yes. We adhere to the highest standards of professionalism and regard maintaining confidentiality and data security as a cornerstone of our practice. We also comply fully with the requirements of GDPR.

  4. Our medical device regulatory consulting is built around a strict quality framework and we only work with clients who share this commitment to quality. Our CEO is a medical doctor with years of experience in the medical device industry and assumes personal responsibility for every project. Our product development process integrates client feedback throughout product production, ensuring a constant focus on your needs.

  5. We work with clients of all sizes and at all stages of their regulatory compliance journey. Our team are here to help and are happy to respond to general enquiries, even if you don't feel like you know where to start. We are experts at 'tuning in' to your requirements and will guide you through the entire process. Our free MDR Compliance Guide and suite of MDR downloads stand as proof of our commitment to help you understand your obligations under the MDR.

  6. Yes. Software as a Medical Device is an increasingly-important segment of the medical device market. We have extensive experience in building regulatory systems for medical software and offer a special application of all our MDR services for software products. We also offer unique downloads and white papers that focus specifically on Software as a Medical Device.

  7. At its core, working with the MDR is about working with clinical evidence. Whether you need to generate evidence for PMCF, analyse data for writing a CER, or build an MDR-ready PMS system, our medical experts have the clinical acumen to ensure that your clinical evidence is produced and interpreted with the highest levels of professionalism. Medical professionals work with clinical evidence all day. We bring their specialist capabilities directly to your MDR strategy.

  8. We believe in transparency and aim to build long-term relationships with our clients. This commitment is demonstrated by our customer-focused pricing strategy. You pay a small deposit upfront, only paying the balance when the work has been completed to your total satisfaction. For higher-value projects we offer flexible payment packages on an individual basis — please contact a member of our team to find out more.

  9. Yes. Our unique business model allows us to scale to accommodate almost any amount of work. Many of our medical professionals remain clinically active, meaning that we have trained more than we presently need. This system allows us to have ready availability of redundant capacity that can be called upon in the event of a surge in demand. Whatever your requirements, our unique business model allows us to step in faster than any of our competitors.

  10. Yes. We run a number of events throughout the year focusing on specific aspects of MDR compliance. We also offer a limited number of free webinars on a limited basis — subscribe to our newsletter to be notified early when we publish new events. Of course, we also have our extensive MDR Compliance Guide and free MDR downloads suite, both of which offer extensive training on all aspects of MDR compliance.

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