Navigating biological evaluation requirements can be complex and resource-intensive without a clear, forward-looking strategy grounded in current regulations. This session will provide an in-depth overview of the latest updates to ISO 10993-1:2025 and upcoming technical specifications designed to help manufacturers and assessors effectively implement these new expectations.
Attendees will gain insight into how global regulatory authorities are recognizing and aligning with these changes, as well as the risk assessment and management principles driving key revisions.
Finally, the session will outline strategic planning practices that can be applied early in the product development process to streamline biological evaluation activities, minimize delays, and ensure full compliance with ISO 10993-1:2025.
Learning Objectives
- Describe the key changes introduced in ISO 10993-1:2025 and explain how they impact biological evaluation strategies, documentation, and regulatory submissions for medical devices.
- Apply updated risk assessment and risk management principles (e.g., integration with ISO 14971 concepts and evaluation over the device lifecycle) to design scientifically justified, efficient biological evaluation plans.
- Develop proactive biological evaluation strategies that incorporate emerging guidance and technical specifications to minimize lead times while aligning with current expectations of major regulatory authorities.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected]
Speakers
