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

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