Biological Risk Management: More Than Just Passing the Audit

Biological Risk Management: More Than Just Passing the Audit

Biological Risk Management: More Than Just Passing the Audit

Biological risk management is a critical element of medical device safety, yet it is often approached only as a regulatory requirement. In today’s MDR environment, this mindset is no longer sufficient. Regulators increasingly expect a structured, well‑justified and fully integrated approach to biological risks across the entire device lifecycle. This webinar will help you step back and look at biological risk management from a broader perspective, connecting regulatory expectations with practical implementation. Through real‑world insights and best practices, you’ll gain a clearer view of how to build a robust and defensible approach that supports both compliance and patient safety, far beyond simply passing an audit.

In this webinar, you will learn:

• During this webinar, participants will learn:
• How biological risk management fits into the overall Medical Device Risk Management framework required by the MDR.
• How to integrate ISO 14971 and ISO 10993 1 into consistent and defensible risk management process.
• How to identify, estimate and evaluate biological risks
• Regulatory expectations and best practices

Who Should Join?

This webinar is intended for professionals involved in the safety and regulatory compliance of medical devices, including:

• Regulatory Affairs and Quality Managers
• Risk Management and Product Safety Specialists
• R&D and Product Development Engineers
• Toxicologists and Biocompatibility Experts
• Medical Device Manufacturers (especially Class IIa, IIb and III devices)
• Professionals working on MDR compliance, Biological Evaluation Plans/Reports and Technical Documentation