In a recent webinar titled "Strategies for Successful PMCF under EU MDR: Unlocking the Mystery," medical device industry experts Smridula Hariharan and Parvathi Nambiar engaged in an illuminating discussion. They explored cost-effective PMCF strategies, discussed how to adeptly address Notified Body comments, and presented real-world case studies to illustrate successful PMCF implementations. Access

Harnessing AI for Regulatory Compliance In the fast-evolving landscape of the medical device industry, harnessing the power of Artificial Intelligence (AI) is not just advantageous but essential for maintaining regulatory compliance. At Celegence, we recognized the potential of AI to streamline complex processes and enhance efficiency in areas such as writing

Streamline Your MDR & IVDR Document Creation with CAPTIS™ In the intricate world of medical device and in vitro diagnostic regulations, meticulous documentation is paramount. Celegence provides cutting-edge technology solutions tailored to assist medical writers, reviewers, and managers in improving compliance and efficiency. How CAPTIS Can Streamline Your Document Creation For Medical Writers:

The Importance of Post-Market Clinical Follow-up for Medical Devices: Compliance and Beyond Medical Device manufacturers have to follow regulatory frameworks of different countries and regions for access to their markets. The onus is on the manufacturers to ensure continuous monitoring and of the safety and performance of their products. Post market clinical

Helpful Guidelines for Producing Your Systematic Reviews A Systematic Review (SR) is a synthesis of evidence that is identified and critically appraised to understand a specific topic. While SR covers a wide range of issues, its primary application lies in studying the safety/performance and effectiveness of drug treatments, medical device, or alternative treatments.

What is PMCF? The goal of all post-market surveillance (PMS) activities is to ensure that the medical device performs as intended and that any potential safety issues are identified as quickly as possible. One of the most crucial parts of your post-market surveillance activities is the post-market clinical follow-up (PMCF). Post Market Clinical Follow