Day 3 - Wednesday 17th JuneWednesday, 17 June 2026 - CEST Time Zone

• Strategies for navigating diverse regulatory frameworks while ensuring compliance and market access
• Dealing with infrastructure gaps - how to leverage local partnerships and adapting to regional requirements to capitalize on emerging market growth
• IP risk and ensuring protection
• Sharing perspectives on cost-reduction

• Analysing the impact of the current US political climate on the MedTech regulatory landscape
• Discussing strategies for navigating supply chain disruptions and ensuring regulatory compliance amidst geopolitical and economic challenges - what new perspectives are there to supply chain management?
• How can we future-proof? What considerations need to be made in 2026 to stay ahead?

• What has changed in practice since the 2025 update?
• How do regulators assess biological evaluation reports now?
• Exploring common pitfalls and come-backs

• How does biocompatibility converge with clinical evaluations and PMS in 2026?
• Diving into how a life cycle approach integrates biological evaluation into every stage of the medical device lifecycle, from design to post-market surveillance.
• Discussing strategies for aligning biological evaluation with evolving regulatory expectations and risk management practices.

For more information, please contact Neha Singh at niha.singh@informa.com

• Outlining key FDA expectations for medical device design and development, focusing on aligning innovation with regulatory requirements.
• Discussing strategies for integrating regulatory considerations early in the design process to streamline approval pathways.
• Practical take-aways for best practices to balancing device functionality, safety, and compliance to meet FDA standards effectively.

• Understanding the FDA’s risk-based approach to ISO 10993-1 and its application in biological evaluation for medical devices.
• Exploring how manufacturers can align with FDA expectations by integrating risk management into their biocompatibility assessments.

• Exploring scenarios where ISO 10993-17 may not fully address toxicological risk assessment needs for medical devices.
• Looking at how to develop alternative toxicological justifications using scientific data, literature, and risk-based approaches.

• Diving into the critical connection between ISO 10993-1 and ISO 10993-17, focusing on chemical characterization and toxicological risk assessment
• Exploring methodologies for integrating chemical data with toxicological evaluations to ensure comprehensive biological safety assessments.
• Discussing practical insights into aligning chemical characterization and risk assessment processes with regulatory expectations.

Unlock Your Potential in Medical Device Regulatory Affairs:

Learn directly from seasoned regulatory leaders who have navigated successful career paths in the medical device industry. Discover the key decisions, pivotal moments, and strategic moves that propelled them to senior positions.