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
Strategies for Successful PMCF under EU MDR: Unlocking the Mystery – Webinar in partnership with Medtech Intelligence What: Webinar in coordination with Medtech Intelligence - “Strategies for Successful PMCF under EU MDR: Unlocking the Mystery” When: March 6th, 2024, 10:00 am – 11:00 am EST Where: Online Event How: Register Here -
FDA Scheduled Updates for the CDRH Customer Collaboration Portal Including New Features (and Penguins) On December 15, 2023, the FDA will begin the CDRH Portal (Customer Collaboration Portal) deployment in which new features will be added, adjusting the Christmas lights, and sweeping out the hearth. The Portal deployment will run from 21:00
An Inside Look: Formal Meetings Between PDUFA Product Sponsors or Applicants and the FDA On September 22, 2023, the FDA unveiled its draft guidance document, "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products”. Scope and Applicability: This guidance provides recommendations to industry on formal meetings between the FDA
Medical Device Regulatory Updates - November 2023 Extension of EU MDR Transition UKCA Marking 510k Submission using eSTAR Extension of EU MDR Transition The MDR was amended through Regulation (EU) 2023/607, which took effect on March 20, 2023, in accordance with directives from the European Parliament and Council. The primary objective of these
Webinar: Navigating Clinical Evaluation Excellence: A Strategic Guide for Medical Devices What: Webinar - “Navigating Clinical Evaluation Excellence: A Strategic Guide for Medical Devices” When: Tuesday, December 5, 2023, 9:30 am Central US Time | 4:30 pm Central EU Time Where: Online Event How: Register Here Why: Join us in this insightful webinar as
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
CAPTIS Copilot – An AI Assistant Purposefully Built for the Life Science Industry With all the speculation of its wondrous potential or disastrous implications, AI has quickly come to dominate the zeitgeist in 2023. Here at Celegence, our Innovation Lab has been hard at work researching practical, helpful applications of AI within our
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
