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.
Registration is now open for the MedTech Regulatory Intelligence Summit in Washington, DC, May 16-17. Join us as we take a closer look at strategies and best practices in developing an effective and sustainable regulatory strategy for today’s global market.
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.
Participate in our new survey and have a chance to win complimentary access to the Computer Modeling & Simulation Virtual Conference on January 27–28, 2021.
As the proliferation of connected and complex medical devices grows, healthcare providers are more susceptible to cyberattacks.
Post-market requirements outlined in the regulation carry significant process challenges and procedure updates. Start simple and try not to overcomplicate your processes.
