Join Neotron, ToxHub, and VitroScreen on 19 November 2025, at 11:00 AM CET, for an exclusive webinar on Advancing Safety and Compliance in Ophthalmic Medical Devices.
Ophthalmic medical devices, from contact lenses to eye drops and ocular gels, represent a diverse and complex category within the medical device landscape. These products, applied to one of the most sensitive anatomical sites, demand precise and scientifically validated biocompatibility evaluations. Ensuring safety and compliance requires a deep understanding of ocular physiology, toxicological principles, regulatory frameworks, and the interactions between materials, formulations, and packaging.
This expert-led webinar will address the key scientific, regulatory, and technical challenges of evaluating substance-based ophthalmic devices, focusing on best practices for achieving compliance while maintaining product safety, integrity, and performance through its lifecycle.
Key Sessions:
ToxHub
- Regulatory Framework and Classification: From absorption considerations to the justification of non-pharmacological mechanisms of action.
- Packaging and Device–Formulation Interaction: Evaluating extractables, leachables, and material compatibility to ensure ocular safety and product stability.
- Biocompatibility Evaluation: Transitioning from BEP to BER for a robust and scientifically justified safety assessment.
VitroScreen
- Advanced in Vitro Studies: Discover how film-forming and persistency studies using human corneal epithelium models (HCE) provide insights into the permeation, retention, and kinetics of ophthalmic formulations.
- Case Studies: Learn how in vitro testing supports regulatory justification and product optimization with examples of hyaluronic acid-based products.
Neotron
- E&L Testing Excellence: Learn effective strategies for Extractables and Leachables (E&L) studies and how to leverage data across products.
- Case Study: Explore real-world application of analytical E&L testing for ensuring the safety and compliance of ophthalmic medical devices.
This webinar is designed for professionals in regulatory affairs, toxicology, R&D, and quality assurance, providing actionable insights into the evaluation and compliance of ophthalmic medical devices.