Continued Commitment to Patient Well-being
The ultimate goal of all medical devices is to significantly enhance the quality of life for patients. In an ever-evolving regulatory landscape, marked by the introduction of the Medical Device Regulation MDR (EU 2017/745) and the In Vitro Diagnostic Medical Devices IVDR (EU 2017/746), the responsibility is on manufacturers to continuously demonstrate that the benefits of their products outweigh the risks. This necessitates a sustained effort to validate safety and effectiveness through comprehensive clinical data throughout the product's lifecycle.
DeSia’s Expert Approach to PMCF and PMPF
At DeSia, our skilled team is expert at crafting and executing tailored post-market strategies to be sure that your product remains compliant and beneficial:
- Developing Customized Follow-up Plans: We prepare PMCF or PMPF plans that align with the specific needs of your product, leveraging insights from your clinical / performance evaluations.
- Managing Clinical Research Follow-up: Collaborating closely with your team, we manage the ongoing follow-up of clinical research activities, confirming a seamless and effective process.
- Reporting and Analysis: Our experts document and report the findings, providing clear insights into the performance and safety of your product post-market.
Comprehensive PMCF/PMPF Services
DeSia offers an all-encompassing range of PMCF and PMPF services. Our team is dedicated to guiding you through every aspect of PMCF/PMPF implementation, verifying that your medical devices continue to meet regulatory standards and deliver on their promise of improving patient lives.
Engage with DeSia for Post-Market Excellence
To engage our expert services for PMCF and PMPF plans, please reach out to us and we will partner with you to work on your medical devices to maintain their efficacy and safety throughout their market lifespan.
