SMART-TRIAL are made for medical devices. A complete data collection toolbox for Post-Market Clinical Follow-Up (PMCF), Post-Market Performance Follow-Up (PMPF), Clinical Investigations and Clinical Performance Studies. Their dedication towards MedTech is mirrored in their platform design, application, usability, licensing, support and implementation.
MDR Compliance by medical professionals
We combine our subject matter expertise with medical writing & clinical evidence analysis
MDR Compliance made simple
Our unique medical device regulatory consulting services combine industry expertise with the key skills of clinically-active medical professionals.
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Subject Matter Experts
Our team of medical professionals have extensive clinical experience in an array of specialities, giving you access to real subject matter experts for Clinical Evaluation and Clinical Evidence Generation services.
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MDR Compliance Specialists
With years of experience in Medical Writing along with designing & conducting clinical investigations, our MDR-trained healthcare professionals can drive the success of your medical device regulatory strategy.
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Our Clients
We work with medical device companies based in the UK, Europe, the US and Asia, developing MDR strategies for all classes of physical and software medical devices.
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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.
Quality Advisor, Manufacturer, UK
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A comprehensive, detailed and highly professional service.
Regulatory Manager, Manufacturer, UK
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We engaged the services of Mantra Systems to support us with updating our Clinical Evaluation Reports both for MDR (UK) and MDR (EU). 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.
Regular meetings were implemented to ensure understanding of both parties and to discuss and address any findings within individual reports. We would engage the CER services again in the future should the need for further support arise.
Head of Clinical Governance & Regulatory Affairs, Manufacturer, UK
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I really appreciated your job on our medical device CER. It was truly amazing how you managed to get all this done in such a short notice. I'm very pleased with your work.
Chief Executive Officer, Manufacturer, France
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Your service surpassed our expectations and added value across our organisation. We feel much better placed to prepare for the MDR.
Chief Executive Officer, Software Company, UK
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All aspects of communication from Mantra Systems have been excellent from initial contact to the conclusion of the projects. There was excellent communication during the projects, included reviews and discussions helping to maintain the momentum and provide the required outcomes.
The work was performed to excellent standards with every part surpassing expectation. The final reports were of an impeccable standard that I am incredibly confident using going forward as part of my technical files.
Regulatory & QA Manager, Manufacturer, UK
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It was a pleasure working with you. We are completely satisfied with your service and look forward to working with you again.
Chief Executive Officer, Software Company, Denmark
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Our Partners
We have very high standards and carefully select partners with the same commitment to excellence.
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Cognidox is an eQMS platform built on a document management system with a lean approach to design controls and quality compliance. With Cognidox, document control, workflow automation, quality modules, compliant e-signatures and software validation come as standard, and they have a proven track record of helping innovative companies scale and succeed.
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Grantify create best-in-class grant applications for start-ups and SMEs. If your company needs to raise money to cover the product development and regulatory costs required to achieve a CE-mark for your medical device, Grantify have the expertise and record of success which could help you overcome the hurdle of getting your device to market.
Our Team
We are focused on bringing real medical expertise to your MDR compliance strategy. Our combined experience allows us to provide a tailored service of the highest professional standard.
Our medical professionals
Our MDR-trained medical professionals are based in multiple countries and have backgrounds in general surgery, intensive care, general practice, O&G, orthopaedics, paediatrics, emergency medicine and more. Whatever your field, we will match you with a medical professional who is a real subject matter expert.
Leadership
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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.
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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.
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Matthew Stinson
Sales & Marketing Manager
Matthew started in graphic design before transitioning to online sales strategy and social media marketing. Through his career, he has led the digital marketing strategies for multiple businesses and now helps forge our online sales and marketing presence.
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Sandra Gopinath
Clinical Evidence 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 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.
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Richard Jones
Systems Manager
For two decades, Richard has designed and developed digital platforms for both private and public organisations. More recently, he has worked with a medical device company, helping with its regulatory compliance challenges. Richard facilitates PMCF system development, while also leading the technical and security management across all of our systems.
The MDR is an opportunity, not a barrier
The correct approach to MDR compliance can secure market position, differentiate your products from the competition and drive commercial success.
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Our team of medical professionals will help demonstrate the clinical value of your products.
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We will produce a tailored MDR compliance strategy to meet all your regulatory requirements.
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The right approach to MDR compliance now will help you stand out from the competition in the future.
Your products matter
We believe in working together to support innovation and ensure the best MDR compliance strategy for your products.
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Integrity We are open and honest and believe in transparency at every step.
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Fairness We believe in equal opportunities and reward hard work and initiative.
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Professional We set the highest standards for our business and our attitude to others.
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Dedicated We specialise solely on MDR 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.
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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 MDR consultation, so please feel confident about discussing your requirements with a member of our team.
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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. Contact one of our teams to start your conversation today.
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Our medical device regulatory consulting services are 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.
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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 EU MDR Compliance Guide and EU MDR Downloads stand as proof of our commitment to help you understand your obligations under the MDR.
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Yes. Software as a Medical Device (SaMD) is an increasingly-important segment of the medical device market. We have extensive experience in building regulatory systems for medical device 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.
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At its core, working with the MDR is about working with clinical evidence. Whether you need to generate clinical evidence for PMCF, analyse data for writing a CER, or get your software application MDR-ready, 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.
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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.
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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.
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Yes. We run a number of free webinars on a limited basis throughout the year — subscribe to our newsletter to be notified early when we publish new events. Of course, we also have our extensive EU MDR Compliance Guide and EU MDR Downloads, both of which offer extensive training on all aspects of MDR compliance.
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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.