Mastering the Complexity of Periodic Safety Update Reports (PSUR)

Date: Nov 1,2024

Time: 1 PM -2:30 PM ET

Duration: 90 Mins

Description

In the ever-evolving landscape of medical device regulations, ensuring compliance with the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) is paramount. One critical aspect of post-market surveillance is the Periodic Safety Update Report (PSUR). Join our highly informative and advanced webinar to gain comprehensive knowledge and understanding of the new EU MDR and IVDR regulatory requirements, enabling you to navigate the complex realm of PSUR implementation with confidence.

Why Should You Attend?

The implications of non-compliance with the EU MDR and IVDR can be dire for your organization, including costly penalties, reputational damage, and potential disruptions to your product portfolio. By attending this webinar, you will acquire the essential insights and strategies to develop, implement, and update your post-market surveillance system to meet the rigorous PSUR requirements. Stay ahead of the curve and safeguard your organization's compliance and reputation.

Areas Covered in the Webinar:

1. Post-Market Surveillance (PMS): Understand the critical role of PMS in ensuring the safety and performance of medical devices. Explore the regulatory requirements and best practices for establishing an effective PMS system that aligns with the EU MDR and IVDR.
2. Periodic Safety Update Reports (PSUR): Unravel the intricacies of PSURs, including their purpose, content, format, and submission timelines. Gain a comprehensive understanding of the key elements that should be included in PSURs to satisfy regulatory expectations.
3. Implementation Strategies: Discover proven strategies for developing and implementing robust Quality Management System (QMS) procedures and templates to support PSUR creation and submission. Learn how to establish/update your existing processes to ensure seamless compliance with EU MDR and IVDR requirements.
4. Regulatory References and Best Practices: Explore a wealth of regulatory references, guidelines, and industry best practices to enhance your understanding of PSURs. Gain valuable insights into key regulatory documents and standards that will shape your PSUR implementation journey.

Who Will Benefit:

This highly advanced webinar is designed to benefit a wide range of professionals involved in regulatory affairs, quality engineering, post-market complaint analysis, project and product management, engineering, manufacturing, and clinical affairs. Whether you are a beginner seeking a solid foundation or a senior-level expert looking to refine your knowledge, this webinar will equip you with the necessary skills and strategies to navigate the intricacies of PSUR implementation.

Do not miss this exceptional opportunity to master the complexity of Periodic Safety Update Reports under the EU MDR and IVDR. Develop a comprehensive understanding of the regulatory requirements, streamline your post-market surveillance processes, and safeguard your organization's compliance and success.

Host or Publisher COMPLYPURE