Medical Minds for Market Access

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.

Regulatory Affairs

  • 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.

  • 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.

  • Sandra Gopinath on LinkedIn Sandra Gopinath Senior Regulatory Specialist

    Sandra is a biomedical engineer with a demonstrated history of working in the medical device industry. She started her career as a project engineer and holds experience as a key accounts manager and application specialist. She obtained a distinction for her master's degree in Biomedical Engineering at Newcastle University, specialising in biomechanics and medical device regulation. Her background provides the perfect blend of scientific insight and knowledge of applied science for her role at Mantra Systems.

  • Dr Gayle Buchel on LinkedIn Dr Gayle Buchel Lead 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 a member of the core team.

  • Dr Hanna Gul on LinkedIn Dr Hanna Gul Lead Medical Writer

    Hanna is a qualified medical doctor, with 13 years' experience in both acute and chronic care settings. She obtained a distinction for her master's degree in Musculoskeletal Science at the University of Oxford and is currently completing a post-doctorate degree at the University of Leeds. Hanna has spent 5 years working in medical research, during which she designed and led multiple clinical trials, in addition to engaging with ethics committees and regulatory bodies.

  • 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 bring 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.

Operations

  • 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.

  • 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.

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 A simple, comprehensive and free guide to working with the EU MDR.

Free download — MDReady Starter Guide Free Download

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