Post Approval Support
Navigating the Evolving Landscape of Medical Device Compliance with Tridios
Getting regulatory approval is only the first step in the constantly changing world of medical devices. Beyond this point, the device lifecycle necessitates ongoing vigilance, data management, and compliance.
At Tridios, we understand that the process doesn’t stop with approval; it continues into an area where quality, ability to adapt, and legal conformity are necessary. Here’s how Tridios may serve as your reliable business partner. We can streamline the process of updating critical documents, including Risk Management, Clinical Evaluation, and other technical documentation, to meet post-approval requirements.
A crucial post-approval requirement is the timely collection of post-market surveillance (PMS) data and the updating of the PMS Report. Tridios can assist you with gathering information, compiling a PMS Plan and Report, and carrying out exhaustive surveillance operations in accordance with regulatory norms.
When it comes to devices that need post-market clinical follow-up, our expertise ensures that your PMCF studies are carried out effectively, producing insightful data that helps you make well-informed decisions and evaluate the long-term performance and safety of your devices.