Powerful medical device registries for 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
Our range of exclusive online workshops are designed to facilitate learning without the expense of travel and accommodation.
We offer a range of training events to familiarise stakeholders from across the industry to all aspects of the new MDR. Our events are targeted for:
More information about the MDR Compliance for CEOs/CFOs online workshop
More information about the Software as a Medical Device online workshop
More information about the Clinical evidence in the MDR online workshop
More information about the MDR Compliance for Class I devices online workshop
Our team of MDR professionals are medical device regulatory consulting specialists offering tailored MDR compliance services.
Powerful medical device registries for 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
Market-leading Clinical Evaluation and CER-writing service delivered by MDR-trained medical professionals with extensive data assimilation and medical writing expertise.
Find out more about our Clinical Evaluation consulting service
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
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.
Find out more about our Software as a Medical Device consulting service
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.
Get exclusive free access to our MDR downloads written and compiled by our in-house medical specialists.
Our unique EU MDR Compliance Guide covers all aspects of the new Medical Device Regulation and is free to use.
Keep up to date with our medical team's insights and analysis on the latest medical device regulation news.
Keep up to date with our thoughts on the industry. All our articles
5 methods every medical device manufacturer should know to improve their Post-Market Clinical Follow-up studies.
Our CEO Dr Paul Hercock was invited to speak on a Kaizen Life Sciences podcast about the challenges posed by the new EU MDR.
Working with the MDR requires knowing how to work with clinical evidence. Medical doctors are perfectly positioned to meet this requirement.