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
• Navigating supply chain turbulence
• Sharing perspectives on cost-reduction

As global regulatory frameworks rapidly evolve, and disruptive technologies like generative AI reshape how we work, MedTech organizations face increasing complexity in bringing safe, effective innovations to market. Navigating this landscape requires a more strategic, forward-looking approach to regulatory planning.

In this session, we’ll explore how to:

· Think beyond traditional markets by identifying and aligning with country-specific regulations outside of the US and EU, while tailoring requirements to product types and therapeutic areas

· Shift regulatory strategy by embedding global regulatory planning early in the product design phase to accelerate and de-risk worldwide launches

· Harness AI pragmatically to streamline regulatory operations, accelerating requirements gathering, adapting to regulatory and manufacturing changes, and unlocking institutional knowledge to enable faster, more efficient global registration approvals

Join us to discover practical strategies that blend regulatory expertise with emerging technology, helping your organization move faster, stay compliant, and compete globally with confidence.

• What has changed in practice since the ISO 10993-1 2025 update?
• How do regulators assess biological evaluation reports now?
• Exploring common pitfalls and come-backs

• Understanding the USA'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.

• 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.

• 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.

• Diving into the critical connection between ISO 10993-1 and ISO 10993-18, 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.