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.
Get our free White Paper: Mastering the MDR — A comprehensive 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 also 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.
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 philosophy
MDR Consulting
Our team of MDR professionals are medical device regulatory consulting specialists offering tailored MDR compliance services.
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Powerful medical device registries and surveys for MDR Post-Market Clinical Follow-up (PMCF) designed by medical experts and driven by leading-edge eCRF, ePRO and data storage systems.
Find out more about our Post-Market Clinical Follow-up consulting service
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Complete Post-Market Surveillance (PMS) system design and implementation by medically-trained specialists. Comprehensive data collection, analysis and reporting for MDR compliance.
Find out more about our Post-Market Surveillance consulting service
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Market-leading Clinical Evaluation and CER-writing service delivered by highly-skilled professionals with extensive data assimilation and medical writing expertise.
Find out more about our Clinical Evaluation consulting service
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Comprehensive Gap Analysis service using advanced clinical techniques to identify and minimise any gaps in your clinical evidence portfolio, guiding your MDR transition strategy.
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We address the unique challenges of applying MDR requirements to medical software through special applications of our PMCF, PMS, Clinical Evaluation and Gap Analysis services.
Find out more about our Software as a Medical Device consulting service
Get our free White Paper: PMS in the MDR — A complete summary on medical device Post-Market Surveillance
MDR Training
Our comprehensive training services are delivered by experts and address all aspects of MDR compliance.
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Benefit from the clinical knowledge of our specially-trained medical professionals and learn how to integrate their expertise into your MDR compliance strategy.
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Our range of exclusive online workshops are designed to facilitate learning without the expense of travel and accommodation.
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Get expert training in all aspects of the MDR and its application to regulatory approval of your medical devices. Seminars can be tailored to specific groups.
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Embed one of our expert medical professionals into your company to provide tailored and personalised training to your team.
Latest updates
Keep up to date with our thoughts on the industry. All our articles
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Increasing data entry compliance in PMCF studies
5 methods every medical device manufacturer should know to improve their Post-Market Clinical Follow-up studies.
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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.
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.
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Get exclusive free access to our MDR downloads written and compiled by our in-house medical specialists.
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Our unique EU MDR Compliance Guide covers all aspects of the new Medical Device Regulation and is free to use.
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Keep up to date with our medical team's insights and analysis on the latest medical device regulation news.
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, 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 medical device regulatory consulting is 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.