Medical device risk management is not optional – it is a regulatory requirement worldwide.
But with today’s medical device regulatory environment changing faster than ever, and the confusion that can come with Risk Management, it doesn’t mean it’s easy.
The Risk Management True Quality Summit Series will help quality, regulatory and product development professionals and executives understand and implement risk management concepts that can help meet FDA, ISO 14971, ISO 13485:2016, and the MDR 2017/745 requirements for risk management.
We’ll dive into the standards and outline deliverables at each stage of the risk management process, explore practical solutions for applying the standards within your organization, and ultimately give you tools to ensure risk management lives throughout your entire product life cycle.
Key Benefits Include:
- Gain insights for the application of ISO 10993-1
- Understand the use of a risk-based approach in biological evaluations
- Provided Real-life Examples of device classifications and used approaches