As regulatory bodies increasingly recognize the richness and value of RWE, particularly in informing the benefit-risk profile of devices from real-world environments, MedTech companies are turning to advanced analytical tools to navigate this new landscape efficiently.
Smridula Hariharan leads a team of medical writers who work on CEPs, CERs, PMS Plan, Post-Market Surveillance Reports, Periodic Safety Update Reports, Post-Market Clinical Follow-up Plan and Reports, for devices spanning a wide range of therapeutic areas. Here, she shares secrets to cost-effective PMCF strategies in the dynamic landscape of the European Medical Device Regulation (MDR).
“Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” outlines how FDA’s medical product centers plan to address regulation of AI used in medical products and their development.
Post-market surveillance plays a critical role in the UK’s medical device regulatory framework. Manufacturers must prioritize establishing a comprehensive PMS system, developing clear and organized PMS plans, and promptly reporting incidents and corrective actions.
Ensuring the safety and efficacy of healthcare products is of utmost importance. The clinical evaluation process of medical devices is vital for demonstrating the device’s safety and performance in accordance with the regulatory requirements. How are device makers navigating this complex process effectively.
The draft regulations, “The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023,” serve as an amendment to the existing UK MDR Part 4A post market surveillance requirements, and are currently with the World trade Organisation (WTO) for member comments.
The FDA is seeking input from organizations interested in collaborating with the agency on the development and execution of the medical device active surveillance system, which is focused around achieving better data capture and detection of potential safety signals in a timely manner. Response required by March 10.
The two new members bring more than 40 years of leadership and IT experience to the HUMA.AI advisory boards, following a recent round of funding and the introduction of new post-market surveillance technologies.
With only one month until the compliance deadline, many medical device companies still have much to prepare in order to meet the requirements.
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