Medical Minds for Market Access

We are an international network of subject matter experts & TOPRA-registered regulatory professionals

Dr Victoria Cartwright, Relationship Manager

We are medical device regulatory experts

Medical device regulation can be a complicated landscape to navigate. Ensure your medical devices are compliant by working with industry-leading specialists with a 100% regulatory submission success rate.

Our Clients say

  • A comprehensive, detailed and highly professional service.

    BG

    Regulatory Manager Manufacturer, UK

  • Please thank all of your team for their brilliant efforts. Your standard of service, response time, and rigour were outstanding and I would strongly recommend you to any other potential client.

    AB

    Quality Advisor Manufacturer, UK

Our Team

We are focused on bringing subject matter expertise to your regulatory strategy. Our combined experience allows us to provide a tailored service of the highest professional standard.

Leadership

  • Dr Paul Hercock on LinkedIn Dr Paul Hercock Chief Executive Officer

    Paul is a qualified medical doctor, law graduate and author. As a doctor, he spent 14 years in a range of acute and critical care settings. Upon leaving clinical practice he served as a 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 the delivery of our market-leading regulatory services.

  • Richard Jones on LinkedIn Richard Jones Operations Director

    For over two decades, Richard has worked with organisations to design and develop digital platforms, manage technical infrastructure and ensure the smooth operation of their critical business systems. His experience in digital and medical device startups gives him a great perspective to direct Mantra Systems' core systems.

  • Sandra Gopinath on LinkedIn Sandra Gopinath Chief Regulatory Officer

    Sandra is a biomedical engineer with a strong medical device background and years of Regulatory Affairs experience. She obtained a Master's in biomedical engineering from Newcastle University, specialising in biomechanics and medical device regulation. Her background and comprehensive experience have equipped her with a deep understanding of both technical and regulatory aspects of medical device development. This provides a strong foundation for her leadership role, where she helps medical device manufacturers to achieve market access.

  • Dr Gayle Buchel on LinkedIn Dr Gayle Buchel Chief Medical Writer

    Gayle is a qualified medical doctor, with 17 years of experience in various areas of the medical field, having worked in both government healthcare and private practice. She founded and ran her own medical practice for 9 years. Gayle began her medical affairs career as a trainee on the Mantra Systems' Associate Program and is now our Chief Medical Writer.

Regulatory & Medical

  • Dr Clare Dixon on LinkedIn Dr Clare Dixon Regulatory Specialist

    Clare is a bioscientist with research experience in the biopharmaceutical industry. She obtained a PhD from Newcastle University and has held a post-doctoral position in Clinical Biochemistry at Manchester University. She worked for more than 10 years as a Technical Writer for a multi-national medical device company and so her combined research knowledge plus background in medical writing brings a wealth of experience to her role at Mantra Systems.

  • Dr Simon Cumiskey on LinkedIn Dr Simon Cumiskey Lead Medical Writer

    Simon is a qualified medical doctor with 4 years of experience across multiple hospital specialities. Whilst predominantly working in the Emergency Department, he also has experience in anaesthetics, critical care, and general internal medicine. Simon spent 18 months working on Mantra Systems' Associate Program before joining the core team as a Lead Medical Writer.

  • Shen May Khoo on LinkedIn Shen May Khoo Junior Regulatory Specialist

    Shen May is a recent graduate with a master's in Pharmacology from King's College London. During a year-long placement at the MHRA, she delved into the intricacies of international standards for in vitro diagnostics, gaining invaluable insights into the ever-evolving regulatory landscape. Shen May brings a passion for ensuring the safety and compliance of medical devices to her role at Mantra Systems.

  • Kamiya Crabtree on LinkedIn Kamiya Crabtree Regulatory Medical Writer

    Kamiya holds a first-class degree in Biomedical Science from Sheffield Hallam University. With extensive laboratory experience and a background working alongside medical professionals in various healthcare settings through placements and volunteering, she brings a passion for cutting-edge medical devices and biomedicine to Mantra Systems.

  • Ronghe Xu on LinkedIn Ronghe Xu Regulatory Medical Writer

    Ronghe graduated with a Master's degree in Medical Affairs from King's College London, where she gained a comprehensive understanding of both pharmaceutical and medical device regulatory affairs. Her expertise in medical and scientific writing brings valuable skills to excel in her role at Mantra Systems, enabling the company to provide its market-leading regulatory services.

  • Subject Matter Experts on LinkedIn Subject Matter Experts Medical Reviewers & Writers

    Our team of over 50 subject matter experts, are active medical clinicians based around the world. They offer an unparalleled ability to critically evaluate the safety and performance of a medical device, with specific insight into how the device directly impacts patient care. We match projects to our subject matter experts who work within the clinical field of the device under evaluation, providing the perfect foundation for clinical evidence generation, identification, appraisal & analysis.

Operations

  • Dr Victoria Cartwright on LinkedIn Dr Victoria Cartwright Relationship Manager

    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. This perspective allows Victoria to nurture and manage everyone at Mantra Systems to their best potential.

  • Simon Hawksworth on LinkedIn Simon Hawksworth IT Manager

    Simon has over 7 years experience working in the healthcare and finance industries providing technical support across the IT systems landscape. He has worked at several large institutions managing their IT systems to a senior level. Simon is well positioned to help lead Mantra Systems' IT strategy and develop secure and efficient systems required in the fast-moving regulatory environment.

  • Beverly Frain on LinkedIn Beverly Frain Office Manager

    As an experienced Office Manager, Beverly ensures Mantra Systems' Accounts, Health & Safety, Human Resources and document administration are diligently overseen. Her attention to detail, focus on efficiencies and proactive approach to organisation, keeps our operations running smoothly and efficiently.

Our Clients say

  • Your service surpassed our expectations and added value across our organisation. We feel much better placed to prepare for the MDR.

    KW

    Chief Executive Officer SaMD Company, UK

  • We engaged the services of Mantra Systems to support us with updating our CERs for multiple devices both for the EU & UK MDR. From start to finish the engagement and communication has been proactive and timely, keeping us updated throughout the entire process, and the quality of the reports fully met our needs.

    PW

    Head of Clinical Governance & Regulatory Affairs Manufacturer, UK

Our Partners

We have very high standards and carefully select partners with the same commitment to excellence.

MDReady Starter Guide Begin your EU MDR compliance journey with a free step-by-step guide

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Your products matter

We believe in working together to support innovation and ensure the best regulatory compliance strategy for your products.

  • 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 on medical device regulation so we can provide a 100% focused service.

Do you need help with your regulatory strategy?

Talk to us