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.
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.
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:
- Product Specialists
- Regulatory Managers
- Anyone who wants to learn more about the new regulations
Due to the current coronavirus pandemic, our live seminars have been transitioned to our online workshops. When restrictions are lifted enough, we will run live seminars again. Sign up to our newsletter to get email notifications when we open new events.
Our team of MDR professionals are medical device regulatory consulting specialists offering tailored MDR compliance services.
Market-leading Clinical Evaluation and CER-writing service delivered by MDR-trained medical professionals with extensive data assimilation and medical writing expertise.
Complete Post-Market Surveillance (PMS) system design and implementation by medically-trained specialists. Comprehensive data collection, analysis and reporting for MDR compliance.
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 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
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.