Post-Market Clinical Follow-up (PMCF) surveys have become a vital tool for ongoing assessment and validation of device performance and safety. The integration of ISO 14155 guidelines into PMCF activities offers regulatory professionals a robust framework to ensure thorough and compliant post-market surveillance. This blog aims to shed light on how ISO 14155 influences PMCF surveys and how professionals can harness its guidelines to optimize post-market activities.
ISO 14155, titled ‘Clinical investigation of medical devices for human subjects — Good clinical practice,’ while primarily known for guiding pre-market clinical trials, also provides invaluable insights for conducting PMCF surveys. These surveys are essential components of a medical device’s lifecycle, offering real-world data critical for assessing long-term safety and effectiveness.
Regulatory professionals play a key role in integrating ISO 14155 into PMCF activities. Their expertise ensures that post-market surveillance not only complies with regulatory requirements but also adheres to the highest standards of ethical conduct and data integrity.
Implementing ISO 14155 in PMCF surveys can present challenges, particularly in aligning post-market activities with the rigor of a standard primarily designed for pre-market clinical trials. Professionals must navigate these challenges by adapting the standard’s principles to the specific context of PMCF surveys.
The integration of ISO 14155 into Post-Market Clinical Follow-up (PMCF) surveys marks a significant stride in medical device regulation and safety. For regulatory professionals, this is not just about compliance but about elevating post-market surveillance to a higher standard. As the only global market research agency that is ISO 14155-compliant, Cetas Healthcare is setting a new industry benchmark in the conduct of PMCF surveys. Our rigorous adherence to these comprehensive guidelines ensures that we are at the forefront of ensuring that medical devices continue to meet the highest possible standards of safety and effectiveness in real-world scenarios. Know more about our Clinical and Regulatory Services(redirect to clinical page)