Defining the Gray Zone - examining the challenges of regulating AI-enabled medical devices and their convergence with non-device technologies.
Exploring existing and emerging regulatory approaches to address the blurred lines between AIeMD and non-device solutions.
Highlighting the impact of this convergence on manufacturers, regulators, and healthcare providers, with strategies to navigate compliance and innovation.
- Risk mitigation in data infrastructure - addressing compliance risks within data management systems
- Streamlining internal communication - identifying friction points to enhance collaboration across teams
- Effective data protection prioritization for manufacturers - exploring strategies to prioritize data protection effectively
Examining how EU MDR revisions are reshaping the definition of risk acceptance in medical device development.
Adapting to change - providing actionable insights for manufacturers to align risk management practices with the new regulatory expectations.
- Highlighting the latest regulatory changes and their implications for accelerating innovation in the MedTech sector.
- Addressing common hurdles and lessons learned to guide stakeholders in bringing breakthrough devices to market successfully.
- Exploring how SMEs can best leverage the breakthrough medical device pathway to compete in the MedTech industry.
Strategies for aligning product development and approval processes to meet diverse regulatory requirements across regions.
Exploring opportunities for harmonization and collaboration to streamline global market access and reduce regulatory complexity.
This intensive workshop provides essential strategies and actionable insights for SMEs operating in the rapidly evolving medical device regulatory sector. As the space industry faces increased regulatory complexity, small and medium enterprises need specialized guidance to not just survive, but thrive in this competitive landscape. This interactive session combines expert-led presentations with hands-on breakout activities, peer networking opportunities, and real-world case study analysis.
Key workshop features include:
- Building a regulatory strategy
- Navigating innovation pathways
- Cost efficiency planning in clinical studies
- Technical file preparation
- Investor perspectives on SME funding
- Pricing & reimbursement insights
- Reviewing key insights gained from data collection requirements under the AI Act and their implications for compliance.
Addressing practical obstacles in meeting data collection standards, including transparency, quality, and governance.
Exploring how organizations can adapt their data strategies to align with evolving requirements and ensure long-term compliance.
This intensive workshop provides essential strategies and actionable insights for SMEs operating in the rapidly evolving medical device regulatory sector. As the space industry faces increased regulatory complexity, small and medium enterprises need specialized guidance to not just survive, but thrive in this competitive landscape. This interactive session combines expert-led presentations with hands-on breakout activities, peer networking opportunities, and real-world case study analysis.
Key workshop features include:
- Building a regulatory strategy
- Navigating innovation pathways
- Cost efficiency planning in clinical studies
- Technical file preparation
- Investor perspectives on SME funding
- Pricing & reimbursement insights
- Exploring the objectives and key differences between the Swiss and the EU regulatory system.
- Addressing the key challenges and timelines
- Practical strategy for manufacturers to navigate swissdamed and ensure seamless market access in Switzerland.
- An overview of the key features of new EU product liability framework, with a focus on new legal risks for software developers.
- An understanding of the growing role of product safety compliance in product liability litigation.
- An update on transposition across the EU, and how to prepare for claims alleging harm caused by SaMD and AI.
Sharing first-hand experiences of SMEs in preparing for compliance, including resource and knowledge gaps.
Offering actionable steps and best practices for SMEs to meet the EU AI Act deadline effectively.
- Key Updates in the EU MDR revision proposal - Overview of proposed changes and latest negotiations
- Implications for Stakeholders - Challenges for manufacturers, Notified Bodies, and healthcare providers, including dual compliance burdens and patient safety improvements.
- Global and Strategic Outlook - Anticipating future bottlenecks, and positioning of the EU within the global MedTech landscape.
This intensive workshop provides essential strategies and actionable insights for SMEs operating in the rapidly evolving medical device regulatory sector. As the space industry faces increased regulatory complexity, small and medium enterprises need specialized guidance to not just survive, but thrive in this competitive landscape. This interactive session combines expert-led presentations with hands-on breakout activities, peer networking opportunities, and real-world case study analysis.
Key workshop features include:
- Building a regulatory strategy
- Navigating innovation pathways
- Cost efficiency planning in clinical studies
- Technical file preparation
- Investor perspectives on SME funding
- Pricing & reimbursement insights
For more information, please contact Neha Singh at niha.singh@informa.com
- The clash between the Digital Omnibus on AI and the MDR/IVDR Proposal - What does this mean for MDAI manufacturers?
- The role of Article 6(1) in defining high-risk AI systems and its impact on medical devices.
- Strategic planning for manufacturers - Preparing for dual compliance or streamlined MDR/IVDR obligations.
- The broader implications of regulatory uncertainty for innovation in MedTech AI.
- Discussing the MDR/IVDR proposal -moving MDAI from Section A to Section B of Annex I
- Extended grace periods under the Digital Omnibus on AI - What do the new timelines mean for compliance planning?
For more information, please contact Neha Singh at niha.singh@informa.com
- How evolving regulations are impacting the design, approval, and lifecycle management of single-use and reusable devices.
- Addressing the relationship between hospital autonomy and manufacturer-driven device usage recommendations.
- Legal and ethical implications of device failures, who bears the responsibility—manufacturers, hospitals, or third-party reprocessors?
Exploring how AI drift impacts the accuracy and reliability of medical devices over time and the need for proactive monitoring strategies.
Evolving Post-Market Surveillance - addressing the role of PMS in detecting and mitigating AI drift through continuous monitoring, real-world data validation, and performance assessments.
Exploring the importance of explainable AI in building trust among stakeholders by making AI decisions more transparent and understandable.
Addressing the growing demand for explainability in AI to meet regulatory requirements and ensure ethical decision-making in critical applications.
Discussing tools, techniques, and challenges in integrating explainable AI into real-world systems without compromising performance.
- Key Updates in the EU MDR revision proposal - Overview of proposed changes and latest negotiations
- Implications for Stakeholders - Challenges for manufacturers, Notified Bodies, and healthcare providers, including dual compliance burdens and patient safety improvements.
- Global and Strategic Outlook - Anticipating future bottlenecks, and positioning of the EU within the global MedTech landscape.
- The clash between the Digital Omnibus on AI and the MDR/IVDR Proposal - What does this mean for MDAI manufacturers?
- The role of Article 6(1) in defining high-risk AI systems and its impact on medical devices.
- Strategic planning for manufacturers - Preparing for dual compliance or streamlined MDR/IVDR obligations.
- The broader implications of regulatory uncertainty for innovation in MedTech AI.
Examining how EU MDR revisions are reshaping the definition of risk acceptance in medical device development.
Adapting to change - providing actionable insights for manufacturers to align risk management practices with the new regulatory expectations.
- How evolving regulations are impacting the design, approval, and lifecycle management of single-use and reusable devices.
- Addressing the relationship between hospital autonomy and manufacturer-driven device usage recommendations.
- Legal and ethical implications of device failures, who bears the responsibility—manufacturers, hospitals, or third-party reprocessors?
- Risk mitigation in data infrastructure - addressing compliance risks within data management systems
- Streamlining internal communication - identifying friction points to enhance collaboration across teams
- Effective data protection prioritization for manufacturers - exploring strategies to prioritize data protection effectively
- Highlighting the latest regulatory changes and their implications for accelerating innovation in the MedTech sector.
- Addressing common hurdles and lessons learned to guide stakeholders in bringing breakthrough devices to market successfully.
- Exploring how SMEs can best leverage the breakthrough medical device pathway to compete in the MedTech industry.
For more information, please contact Neha Singh at niha.singh@informa.com
Strategies for aligning product development and approval processes to meet diverse regulatory requirements across regions.
Exploring opportunities for harmonization and collaboration to streamline global market access and reduce regulatory complexity.
For more information, please contact Neha Singh at niha.singh@informa.com
- Exploring the objectives and key differences between the Swiss and the EU regulatory system.
- Addressing the key challenges and timelines
- Practical strategy for manufacturers to navigate swissdamed and ensure seamless market access in Switzerland.
- Discussing the MDR/IVDR proposal -moving MDAI from Section A to Section B of Annex I
- Extended grace periods under the Digital Omnibus on AI - What do the new timelines mean for compliance planning?
Exploring the importance of explainable AI in building trust among stakeholders by making AI decisions more transparent and understandable.
Addressing the growing demand for explainability in AI to meet regulatory requirements and ensure ethical decision-making in critical applications.
Discussing tools, techniques, and challenges in integrating explainable AI into real-world systems without compromising performance.
Exploring how AI drift impacts the accuracy and reliability of medical devices over time and the need for proactive monitoring strategies.
Evolving Post-Market Surveillance - addressing the role of PMS in detecting and mitigating AI drift through continuous monitoring, real-world data validation, and performance assessments.
Defining the Gray Zone - examining the challenges of regulating AI-enabled medical devices and their convergence with non-device technologies.
Exploring existing and emerging regulatory approaches to address the blurred lines between AIeMD and non-device solutions.
Highlighting the impact of this convergence on manufacturers, regulators, and healthcare providers, with strategies to navigate compliance and innovation.
- An overview of the key features of new EU product liability framework, with a focus on new legal risks for software developers.
- An understanding of the growing role of product safety compliance in product liability litigation.
- An update on transposition across the EU, and how to prepare for claims alleging harm caused by SaMD and AI.
- Reviewing key insights gained from data collection requirements under the AI Act and their implications for compliance.
Addressing practical obstacles in meeting data collection standards, including transparency, quality, and governance.
Exploring how organizations can adapt their data strategies to align with evolving requirements and ensure long-term compliance.
Sharing first-hand experiences of SMEs in preparing for compliance, including resource and knowledge gaps.
Offering actionable steps and best practices for SMEs to meet the EU AI Act deadline effectively.
This intensive workshop provides essential strategies and actionable insights for SMEs operating in the rapidly evolving medical device regulatory sector. As the space industry faces increased regulatory complexity, small and medium enterprises need specialized guidance to not just survive, but thrive in this competitive landscape. This interactive session combines expert-led presentations with hands-on breakout activities, peer networking opportunities, and real-world case study analysis.
Key workshop features include:
- Building a regulatory strategy
- Navigating innovation pathways
- Cost efficiency planning in clinical studies
- Technical file preparation
- Investor perspectives on SME funding
- Pricing & reimbursement insights
This intensive workshop provides essential strategies and actionable insights for SMEs operating in the rapidly evolving medical device regulatory sector. As the space industry faces increased regulatory complexity, small and medium enterprises need specialized guidance to not just survive, but thrive in this competitive landscape. This interactive session combines expert-led presentations with hands-on breakout activities, peer networking opportunities, and real-world case study analysis.
Key workshop features include:
- Building a regulatory strategy
- Navigating innovation pathways
- Cost efficiency planning in clinical studies
- Technical file preparation
- Investor perspectives on SME funding
- Pricing & reimbursement insights
This intensive workshop provides essential strategies and actionable insights for SMEs operating in the rapidly evolving medical device regulatory sector. As the space industry faces increased regulatory complexity, small and medium enterprises need specialized guidance to not just survive, but thrive in this competitive landscape. This interactive session combines expert-led presentations with hands-on breakout activities, peer networking opportunities, and real-world case study analysis.
Key workshop features include:
- Building a regulatory strategy
- Navigating innovation pathways
- Cost efficiency planning in clinical studies
- Technical file preparation
- Investor perspectives on SME funding
- Pricing & reimbursement insights