Day Five – 14 June 2024Friday, 14 June 2024

• From clinical evaluations, to post-market surveillance, to risk management: How do these Standard Operational Procedures (SOPs) feed into each other?
• How would cross-departmental development and delivery enhance working efficiency?
• Shared experiences: breaking bread with breaking silos

• Current regulations regarding PMS activities for devices
  • Similarities and differences
  • Key documentation
• What's working?
  • Current successes and challenges in meeting PMS requirements
• On-going work and future expected guidance

• What do we know about the latest guidance released for PMS and PSURs?
• Has this helped industry to gain a more comprehensive understanding of the requirements?
• How can manufacturers infiltrate this guidance into their day-to-day responsibilities?

• Discuss key regulatory requirements and guidelines that impact manufacturers in terms of post market risk management
• Highlight best practices for implementing robust post-market surveillance based risk management strategies to monitor and assess the safety and performance of medical devices.
• Share insights on leveraging real-world data (reactive and proactive), including adverse event reporting, user feedback, and other sources, to enhance surveillance effectiveness.
• Discuss tools, frameworks, and case studies that demonstrate effective risk analysis, including proactive identification of emerging risks.
• Discuss strategies for continuous improvement in post-market risk management, emphasizing the integration of feedback loops, continuous monitoring, and iterative risk mitigation processes.

Please contact: Roshni Shah – roshni.shah@informa.com

Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar

• Guidance for overall Post Market Surveillance activities
• Correlation between adverse event, incidents, claims and Post Market Surveillance Report
• Successful data gathering from different tools and embedding into the Post Market Surveillance Report

• Introduction to Device Constituents of Combination Products
• US FDA Post-Market Device Safety Reporting Final Rule
• Key Learnings & Implementation Opportunities

• Which requirements are in place regarding PSURs and SSCPs?
  • Are they relevant to both the MDR and IVDR
• How do they both feed into each other?
  • Further link to PMS plans, PMCF and PMPF
• End-to-end development of the documents

Please contact: Roshni Shah – roshni.shah@informa.com

Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panelist, moderator or hosting a webinar

Take the opportunity to have your remaining unanswered questions discussed with our array of experts before the conference ends!

• How do regulatory affairs teams stand to change with the increasing incorporation of AI/ML?
  • Which skills need to take the forefront when working with SaMDs and AI/ML?
  • How can AI be harnessed to enhance internal processes?
• In the next 10 years – where do we see AI/ML going?
  • Are regulatory affairs teams at risk of being overtaken by AI/ML?

• Cybersecurity in regulations
• Who owns the cybersecurity of the device or diagnostic?
  • Incorporation of cybersecurity in the entire product lifecycle
• Testing of cybersecurity
  • Identifying and overcoming weaknesses
  • Enhancing overall security

• Which regulations and standards are applicable to AI-specific QMS?
  • Do they differ largely from static devices or diagnostics?
• Working examples: end-to-end process of developing QMS with AI/ML
  • Opportunities and challenges in development and application

Please contact: Roshni Shah – roshni.shah@informa.com

Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar

• Key QMS processes to consider for the development of AIMD products
• Challenges and tips to obtaining QMS certification for a small organisation
• Q&A

• Preparing a NHS Wales digital organisation for MDR readiness
  • How do we map out MDR requirements?
  • What obstacles need solutions?
• On-going work
  • What does the future hold?
  • How do we maintain compliance and increase development within a publicly funded resource envelope?

• Risk based approach in classification of Medical Device Software and application of GDPR to databases created thanks to pilot clinical trials, promoted by startup companies and spinoff companies
• Interpreting the AI Regulation for startup and spinoff companies in their development from research project to commercial product
• Impact of the regulatory burden in the relationship with investors

• Interpreting PMS requirements for AI/ML
  • Do these differ to traditional medical devices and diagnostics?
• Considerations for static and non-static algorithmic devices and diagnostics
  • On-going data collection
  • Utilising data effectively
• How could cloud based systems enhance PMS plans?

Please contact: Roshni Shah – roshni.shah@informa.com

Or Call +44 (0)7776636553 if you are interested in participating as a speaker, panellist, moderator or hosting a webinar

Take the opportunity to have your remaining unanswered questions discussed with our array of experts before the conference ends!

• Regulatory considerations in early development
• Access publicly available databases early on
• “Can you sell me this pen?” Three easy steps to develop an initial regulatory, quality, and clinical strategy and then sell it to senior management.
• Establishing and initiating the project
  • Mapping out timelines, responsibilities, and management
  • Records management and documentation
  • Identify ways to incorporate quality planning into a project
• Common myths, best practices, and tools – Lessons learned

• Which regulations and standards apply to your device?
• Establishing and monitoring standards in medical device project management
• Incorporating regulatory requirements and considerations throughout the medical device lifecycle (clinical evaluation, safety, and risk management)
• Additional regulatory considerations for project management (quality system requirements, design control, vendor control)
• Common myths, best practices, and tools – Lessons learned

• Systematic literature reviews, appraising and analyzing literature
• Clinical investigations, registries, hospital databases, and surveys
• Post-market activities, complaint handling, vigilance, and CAPA
• Access publicly available databases
• Common myths, best practices, and tools – Lessons learned

• Practicalities of risk management
• Benefit-risk analysis – the unsolvable equation
• Common myths, best practices, and tools – Lessons learned

• Metrics used for project management
• Metrics used for notified body performance
• Adapting to change – significant changes will occur
• Understanding full lifecycle expectations
• Discuss how to optimize team performance, communication, and interaction
• Common myths, best practices, and tools – Lessons learned