A co-operative approach to medical device PMCF

Uniting manufacturers, clinical sites & study investigators in the pursuit of medical device safety

Why we are different

We believe that closer co-operation between healthcare providers and medical device manufacturers enables better, more focused and more effective clinical research.

  • Efficient

    We work to eliminate boundaries to undertaking PMCF studies, saving time, promoting efficiency and ensuring cost-effective study approval.

  • Effective

    Our co-operative approach ensures that parties are aligned on purpose and intent, ensuring more studies get approved and better data is generated.

  • Experienced

    Our team are medical device PMCF experts with extensive experience of initiating PMCF studies at clinical sites.

Leadership

Real medical expertise and extensive experience in the medical device industry forms the core of our leadership team.

  • View Dr Paul Hercock on LinkedIn

    Paul is a qualified medical doctor and spent 14 years in a range of acute and critical care settings. Following his medical training he studied law, graduating with Distinction from Nottingham Law School.

    Paul left clinical practice several years ago to pursue his interest in medical devices. He has served as medical advisor to a number of companies from across the medical device industry, with experience at start-up, mid-size and multi-national level.

    His combination of clinical, legal and industry experience means he is uniquely positioned to lead Mantra Systems and its delivery of highest-quality MDR compliance services.

  • View Richard Jones on LinkedIn

    For over 19 years, Richard has designed and developed user interfaces for organisations including the NHS, BBC, UK universities, banks and government agencies. He has a broad range of skills that encompass programming, user experience design and startup management.

    More recently he has worked with a medical device company helping with its MDR compliance challenges. This has given him a deep understanding of the processes involved in ensuring MDR compliance of medical devices.

    As CTFO for Mantra Systems, Richard has primary responsibility for our digital data security and data handling processes. Richard also manages book-keeping and the financial structure of the business.

  • View Matthew Stinson on LinkedIn

    Matthew began his career in graphic design, before transitioning to focus on web development and social media interfaces. From this, he developed his expertise in search engine optimisation and digital marketing.

    Matthew is central to our ongoing commitment to serve ever-more clients who can benefit from our unique range of services.

  • View Dr Victoria Cartwright on LinkedIn

    Victoria is a trained Chiropractor with extensive clinical experience. Effective chiropractic care goes far beyond the physical treatment of patients, requiring a holistic approach that considers the entire person; their mind, body, personality and needs. This perspective has allowed Victoria to nurture her true passion — working with and effectively managing people.

    Her key skills are in communication, motivation, team-building and support, making her an invaluable COO and the gel that binds the organisation.

Your studies matter

We believe in working together to support innovation and promote medical device safety & performance.

  • Integrity We are open and honest and believe in transparency at every step.

  • Fairness We believe in equal opportunities and reward hard work and initiative.

  • Professional We set the highest standards for our business and our attitude to others.

  • Dedicated We specialise solely in medical device PMCF so we can provide a 100% focused service.

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. No. Clinical sites and investigators are free to join our network and retain full control over which studies, if any, are initiated at their site. Manufacturers are free to consider our recommended sites and pay only when they and the clinical site agree to move forward on the study together.

  2. At the moment, yes. The introduction of new medical device legislation (the MDR) means that there is currently an acute need for manufacturers to conduct medical device Post-Market Clinical Follow-up (PMCF) studies. Our aim is to meet that need and ensure manufacturers can conduct the research they require while hospitals can gain from experience, prestige and industry partnerships through active research participation.

  3. You can - although, in many cases, this can be a slow, expensive and inefficient process. Not all clinical sites are aware of medical device PMCF and, compared to RCTs, participation can be seen as unattractive. Our database of approved clinical sites understand the need for medical device PMCF are are excited, motivated and ready to participate. All they need is the right manufacturer with the right study.

  4. Active participation in clinical research is great for professional development and enables clinicians and healthcare professionals to contribute directly to the promotion of medical device safety. Study participation will be compliantly remunerated and, because PMCF studies often run long-term, this can enable expansion of on-site research departments and provision of dedicated research staff.

Do you need help with your PMCF study?

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