With over 65 years combined experience, we have a long track record of delivering timely solutions for our clients.
PMCF mandates that manufacturers proactively assess and record the safety and performance of their devices throughout their lifecycle once they are on the market. While randomised clinical trials and registries offer higher levels of evidence, they are not always feasible for certain devices. PMCF surveys, however, provide a more practical, cost-effective, and time-efficient alternative.
Odelle Technology has developed a best-practice approach, approved by EU regulators and compliant with GDPR, for conducting high-quality PMCF surveys. These surveys adhere to the standards outlined in ISO 14155:2020 for clinical investigation of medical devices and ISO 20916:2019 for clinical performance studies of in vitro diagnostic medical devices. Our surveys include both general end-user level (Level 8) and high-quality patient level (Level 4) surveys.
With over 650 bespoke PMCF surveys completed across various device types and risk classifications, Odelle Technology can support you with the design, implementation, data collection, and reporting of your PMCF surveys. Ensure your compliance with the EU-MDR by partnering with Odelle Technology today.
For information about PMPF surveys and how they can support your IVDR submission, please contact us.
Ensure your compliance and maintain the highest standards of safety and performance with Odelle Technology’s PMCF services, adhering to the most stringent international standards.