MDR Consulting Services
Our team of medical professionals are specialists at building the regulatory framework and evidence generation systems you need for MDR compliance.
Post-Market Clinical Follow-up
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.
Special application Software as a Medical Device
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.
Use our MDR Requirements Matcher to see which GSPRs apply to your products
Why we are different
We are expertly-trained medical doctors who recognise the crucial role played by medical devices in the provision of quality healthcare.
Our founder, Dr Paul Hercock, has applied his extensive training in medicine, law and medical devices to build a comprehensive platform of expert MDR compliance support services.
This expertise is leveraged through our network of specially-trained medical doctors who work within this platform to apply their clinical acumen to your products.
We match you to an expert clinician who is always available to you to produce the MDR compliance strategy that incorporates medical insight where it is needed most.
Read more about us and our philosopy