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Professional Services
Rotherham South Yorkshire, England, S60 1FE
An effective Post-Market Clinical Follow-up (PMCF) system is an essential component of all regulatory frameworks under the MDR & our in-house team of medical professionals have the clinical experience and extensive knowledge of the study design techniques required for successful regulation of your medical devices.
We will produce a GDPR-compliant data collection system designed around the bespoke needs of your product, enabling investigators and patients to securely input data directly into the PMCF study.
Our PMCF service offers:-
Professional PMCF study design
Detailed knowledge of medical device registry and survey design techniques
Real-time data collection & storage
Curated eCRF, ePRO and data storage systems enabling secure data collection from any device
Technical document writing PMCF Plans, Protocols, Investigator's Brochures, ICFs and PMCF Reports written by medical experts
Start by contacting us for a free consultation and quote to discuss your PMCF, clinical evaluation, systematic literature reviews, medical device writing, EU MDR compliance requirements and other medical device regulatory consulting services.
We also can provide unique resources linking medical device manufacturers with clinicians and hospitals to enable the conduct of PMCF studies. A co-operative approach to improve medical device innovation & safety and encourage research participation amongst healthcare professionals. Visit our clinical investigators website for more information.
