Your MDR compliance. Our medical expertise.
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Benefit from the knowledge of our expertly-trained medical professionals and get ready for the MDR.
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Our extensive library of free resources will guide you through the challenges of MDR compliance.
Download our free Mastering the MDR White Paper — An easily digestible summary of the EU MDR
Who we work with
Our clients come from across the industry and range from pre-start businesses to stockmarket-listed multinationals. We aslo have key strategic partners based in the UK and Denmark.
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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 in future.
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
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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.
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Diversified
Working with us gives you access to our growing international team of MDR-trained healthcare professionals from a wide variety of clinical backgrounds.
Read more about our team and philosopy
MDR Consulting
Our team of medical professionals are specialists at building the clinical evidence portfolio that you need for MDR compliance of your products.
Use our MDR Requirements Matcher to see which GSPRs apply to your products
MDR Training
Our comprehensive training services are delivered by experts and address all aspects of MDR compliance.
Latest updates
Keep up to date with our thoughts on the industry. All our articles
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Simplifying the challenges posed by the new EU MDR
Our CEO Dr Paul Hercock was invited to speak on a Kaizen Life Sciences podcast about the challenges posed by the new EU MDR.
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Why medical doctors can drive MDR compliance
Working with the MDR requires knowing how to work with clinical evidence. Medical doctors are perfectly positioned to meet this requirement.
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Software as a medical device
Unless you have spent time working with medical device legislation in the past, the idea that software could be a medical device may be rather unexpected.
MDR Guidance
Our unique MDR guidance resources are written by our medical experts and free to use. They cover all aspects of the new Medical Device Regulation.
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 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.
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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.
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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.
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Our 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 MDR Compliance Guide and suite of 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 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.
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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.
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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 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.