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
Mastering Compliance: Essential Insights into PMS Documentation – Webinar What: Webinar in partnership with Medtech Intelligence - “Mastering Compliance: Essential Insights into PMS Documentation” When: Wednesday, April 24th, 2024 | 10:00 am – 11:00 am EST Where: Online Event How: Register Here - this webinar will include a 45-minute presentation and 10
The Role of Regulatory Labeling Regulatory labeling regulations play a crucial role in ensuring the safe and effective use of drug products by patients. However, compliance with these regulations can be complex, especially with the introduction of new requirements and updates. Global and Regional Regulatory Labeling Managing global and regional labeling in the
6th Annual Life Science Regulatory Intelligence & Strategy Conference Celegence invites you to join us for the In-Person 6th Annual Life Science Regulatory Intelligence & Strategy Conference presented by Q1 Productions from April 10-11, 2024, in Baltimore, MD, USA. This event brings together global intelligence, strategy, policy and legal experts to share
Dossplorer - Revolutionizing Regulatory Affairs In the fast-paced world of pharmaceuticals, navigating the complexities of regulatory affairs can be daunting. However, with the right tools and solutions, pharmaceutical companies can streamline their processes, save time, and reduce costs significantly.The RSIDM 2024 forum highlighted a crucial focus on improving and optimizing organizational processes and
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.
FDA Updates Recognized Consensus Standards Database with List 61 The U.S. Food and Drug Administration (FDA) has released List 61 which is an update to the Recognized Consensus Standards Database. It includes new standards, updated versions, and revisions to the extent of recognition for existing standards. Facts About This Update One significant
FDA Issues a Final Rule Amending the Quality System Regulation (QSR) The Food and Drug Administration (FDA) has issued a final rule amending the Quality System regulation (QSR). The title of the regulation has also been amended and will now be officially referred to as the Quality Management System Regulation (QMSR). The
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
