Medical device manufacturers must have a thorough understanding of how to identify, assess and manage biological risks to ensure compliance with international regulatory requirements.
Regulatory authorities and notified bodies increasingly expect clear evidence that devices meet the requirements of the ISO 10993 series of standards, with biological evaluations conducted within the broader context of ISO 14971 risk management. A solid grasp of biocompatibility testing is therefore essential, particularly the three foundational tests for cytotoxicity, sensitization and irritation. These tests are critical for demonstrating biological safety and are typically required for most medical devices as part of a comprehensive biological risk assessment strategy.
In this webinar, our experts will share strategic, regulatory and scientific insights to help medical device developers design and implement an effective biocompatibility evaluation plan aligned with ISO 10993. They will explain how to build a coherent risk assessment, align test selection with regulatory expectations and understand how notified bodies assess biological safety data.
The webinar will also feature practical insights into cytotoxicity and irritation testing, showcasing our in vitro capabilities under ISO 10993-5, -12 and -23, along with advancements in animal-alternative methods that support safer, faster and more sustainable evaluations.
Agenda
- Introduction to the ISO 10993 framework for biocompatibility evaluation, including strategies for risk assessment and test planning
- Overview of test principles, sample preparation, extraction conditions and data interpretation
- Overview of irritation testing methods, including animal alternatives and interpretation criteria
- Q&A
Who should attend?
This webinar is ideal for medical device professionals involved in R&D, manufacturing or biocompatibility testing. It is also relevant for those working with products requiring biocompatibility assessments due to use or biological risk, and for professionals with a focus on dermatology.
This event takes place on July 15, 2025, at 10:00 AM (EST).
