As another year unfolds with regulatory changes, updated mandates, and the ongoing impacts of the COVID-19 pandemic, it is crucial for medical device manufacturers to stay informed and prepared. Join leaders from Nelson Labs and Greenlight Guru in this informative session where they will discuss the current state of the industry and provide forecasts for 2022.
This presentation will cover three key areas, detailing the impending changes, their expected timelines, and how manufacturers can effectively prepare:
- Increasing Importance of Quality: With regulatory bodies placing a heightened emphasis on quality, manufacturers must prioritize quality assurance and control in their processes. This segment will explore the specific areas where quality standards are becoming more stringent and the best practices for maintaining compliance.
- Changes to ISO 10993-1: ISO 10993-1, the standard for biological evaluation of medical devices, is undergoing significant updates. This portion of the presentation will outline the key changes, their implications for device testing and approval, and strategies for integrating these updates into existing compliance frameworks.
- The End of the EUA (Emergency Use Authorization): As the pandemic evolves, the temporary allowances under the EUA are expected to conclude. This section will discuss the transition back to standard regulatory pathways, the potential challenges this presents, and how manufacturers can navigate this shift while ensuring continued market access for their products.
By attending this session, participants will gain a comprehensive understanding of the regulatory landscape for 2022, including actionable insights on how to adapt to these changes. This knowledge is crucial for maintaining compliance, ensuring product quality, and effectively managing the transition from pandemic-related regulatory flexibilities.
This presentation is essential for professionals in regulatory affairs, quality assurance, and medical device manufacturing. By staying informed about the latest regulatory trends and updates, participants can proactively address challenges and position their organizations for success in the evolving medical device industry.