Regulatory updates and industry case studies

Can the “Big Three” be addressed using non-animal methods? Scientifically validated in vitro approaches are available to assess cytotoxicity, skin irritation and skin sensitization, supporting more predictive and human-relevant biocompatibility testing. As the regulatory landscape continues to evolve, medical device manufacturers face growing opportunities to incorporate these methods into biocompatibility assessments and regulatory submissions.

Join us for a webinar exploring the latest developments within the ISO 10993 framework and how New Approach Methodologies (NAMs) are being applied in practice. Through regulatory perspectives and industry case studies, our speakers will discuss how in vitro methods can support decision-making from early material screening to CE-marking submissions.

Build readiness
• Develop your NAM database
• Gain testing experience
• Strengthen weight-of-evidence assessments

The webinar will last around 45 minutes, followed by a live Q&A. If you cannot attend the live event, register anyway to receive the recording.

Key takeaways

• Regulatory insights: Stay informed on the latest developments in ISO 10993-5, ISO 10993-23 and ISO 10993-10, and the growing role of in vitro methods.
  
  
• GARD^® advancements: Learn how GARD^® supports both skin sensitization hazard and quantitative potency assessment of extractable medical devices and solid materials in polar and non-polar vehicles.
  
  
• Industry application: Discover how NAMs are used as weight-of-evidence in CE-marking submissions, testing of 3D-printed oral devices, metallic 3D-printing materials, and early-stage material screening.

Speaker

Andy Forreryd, PhD
Scientific Liaison Manager @ SenzaGen

• Co-developer of the GARD^®skin assay (OECD TG 442E).
• Member of the ISO/TC 194/WG 8 on irritation and sensitization.
• Member of OECD expert group on respiratory sensitization.

Additional speakers to be announced