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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.
Our team of MDR professionals are medical device regulatory consulting specialists offering tailored MDR compliance services.
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.
Complete Post-Market Surveillance (PMS) system design and implementation by medically-trained specialists. Comprehensive data collection, analysis and reporting for MDR compliance.
Market-leading Clinical Evaluation and CER-writing service delivered by highly-skilled professionals with extensive data assimilation and medical writing expertise.
Comprehensive Gap Analysis service using advanced clinical techniques to identify and minimise any gaps in your clinical evidence portfolio, guiding your MDR transition strategy.
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.
Our comprehensive training services are delivered by experts and address all aspects of MDR compliance.
Benefit from the clinical knowledge of our specially-trained medical professionals and learn how to integrate their expertise into your MDR compliance strategy.
Our range of exclusive online workshops are designed to facilitate learning without the expense of travel and accommodation.
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.
Embed one of our expert medical professionals into your company to provide tailored and personalised training to your team.
Keep up to date with our thoughts on the industry. All our articles
Increasing data entry compliance in PMCF studies
5 methods every medical device manufacturer should know to improve their Post-Market Clinical Follow-up studies.
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.
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.