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 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

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

Writing a 510(k) for FDA eSTAR Program Adapting your approach to writing a 510(k) to accommodate the new eSTAR requirements is no easy task. The days of writing a creative submission that tells a story of development, safety, effectiveness and substantial equivalence with a beautifully orchestrated flow are over. The old 510(k) format will

Role of Clinical Evaluation Report Consultants In the dynamic landscape of medical device regulations, ensuring the safety and efficacy of healthcare products is of utmost importance. One of the critical aspects of this process is the clinical evaluation of medical devices. A well-written Clinical Evaluation Report (CER) is vital for demonstrating the device's

Systematic Literature Review Tools - How To Choose One A variety of factors (e.g., the new EU MDR & IVDR requirements, finding and retaining top talent, and tight budgets, just to name a few) have influenced Medical Device and Diagnostic manufacturers to invest in technology that streamlines and automates required compliance activities. Systematic Literature