Effective risk management for medical devices and IVDs has never been more critical than it is today. As lessons are learned from real-world incidents and events, consequently, regulatory requirements for safety and performance tighten. As the complexity of devices increases, along with the systems in which they operate, manufacturers must navigate a challenging landscape to ensure the safety and effectiveness of their products. But once you move beyond the requirements of ISO 14971:2019, what sets successful risk management apart? One part of the answer lies in effective communication; from hazard identification, via the disclosure of residual risks, to field safety notices.

Join us for an eye-opening 30-minute presentation and additional 15 minutes of Q&A, where RQM+ Manager of Intelligence and Strategic Execution, Ed Ball, MSc CEng MIPEM, will explore the vital role of communication throughout the risk management activities conducted over the course of the medical devices lifecycle. Drawing from his extensive experience in the industry, having worked for the UK’s MHRA and several device manufacturers, Ed will share insights and strategies to help you elevate your risk management processes.

This session will cover:

  • The importance of communication throughout the risk management process, from design and manufacturing to post-market surveillance
  • Strategies for fostering cross-functional collaboration and ensuring all stakeholders are aligned
  • Techniques for effectively communicating risks and mitigation strategies to regulatory bodies and end-users
  • Real-world examples demonstrating the impact of communication breakdowns and successes in risk management
  • Opportunities to ask your questions and engage with industry peers facing similar challenges

Whether you're a quality assurance professional, regulatory affairs specialist part of a product development team, or working within a healthcare institution, this webinar is designed to equip you with the communication tools and best practices to enhance your risk management efforts. By attending, you'll gain actionable insights to help you proactively identify and mitigate risks, improve device safety, and communicate risk-related information with your customers and end-users alike.

Who should watch:

  • Quality Assurance Managers and Directors
  • Regulatory Affairs Professionals
  • Product Development Teams
  • Risk Management Specialists
  • Clinical Affairs Professionals
  • Post-Market Surveillance Teams

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Manager, Intelligence & Strategic Execution

Ed Ball_1Ed Ball is Manager, Intelligence & Strategic Execution at RQM+ and formerly worked as a medical device specialist at the UK Medicines and Healthcare products Regulatory Agency (MHRA), and is currently an active member of the UK’s Technical Committees for Medical Device Quality Management and Risk Management standards. He is an accomplished medical device specialist and chartered engineer, who combines a technical understanding of medical devices with regulatory and quality management experience. Ed has 15+ years of practical experience with a wide breadth of medical devices, including but not limited to EU Class I – III, active devices, implantable devices, diagnostic devices, measuring devices, devices used by lay people, and sterile devices.