Post-Market Clinical Follow-up

Post-market clinical follow-up (PMCF) has become a necessity for all manufacturers regardless of the type of medical device. It is the instrument that allows the review, and if necessary, updating of the clinical evaluations of the products.

Among other benefits, PMCF allows:

• Identifying specific risks related to the use of the product.
• Identifying usability challenges and opportunities to improve patient safety and well-being.
• Assisting in evidence-based decision-making and continuous improvement of devices to achieve better outcomes for patients.

As part of post-market clinical follow-up (PMCF) activities, the use of follow-up surveys has gained popularity as a method to obtain confirmation of the functioning and clinical safety of products. PMCF surveys for users are presented as an economical alternative to gather clinical information that supports the safety and performance standards of a device. This data is essential to identify potential safety or performance issues with the device and ensure that it still meets the needs of patients and users. However, creating and conducting a high-quality survey presents its challenges.

At CARJES SOLUCIONES, we offer our expertise in conducting post-market clinical follow-up (PMCF) in accordance with current guidelines and standards to ensure both the functioning and clinical safety of products throughout their lifecycle.