This webinar explores how Risk Management is critical to the regulatory frameworks and provides an overview of the fundamental principles and key standards. In addition, it explores some best practices for implementing risk management activities within your organisation, including post-market considerations.
Initially, the context for Risk Management activities is presented which include an overview of a typical device life cycle and where key risk management activities occur. Next, the Risk Management requirements from the Australian, European and US Regulations are compared, and key requirements highlighted. This sets the basis for how a device needs to show compliance to the regulations, through the ISO 14971 standard for medical device Risk Management. The webinar then discusses the application and relationship of this and other standards to the risk management process. It also covers the changes to the ISO 14971 standard introduced in the 2019 edition, and the impact on medical devices.
To help understand the risk management process further, the webinar provides an overview of the ISO 14971 standard, and steps through the key activities, such as Risk Analysis, Risk Evaluation and Risk Control. It provides some discussions on key concepts, providing examples, and techniques for each of these steps. These help to understand what are Hazards, Hazardous situation, Probability of occurrence, severity of harm, risk estimation, and residual risks. It also touches upon the common confusion between Risk Analysis and Risk Management. Later the webinar covers the risk-benefit assessment, and the required production and post-production activities. Finally, best practices are covered which include a look at how risk management processes fit into the product development design control processes and the key activities required with helpful hints.
Key learning objectives:
- Risk Management is an essential component of medical device development and required for regulatory compliance.
- Apply recognised standards such as ISO 14971 to the device life cycle and integrate into your QMS and use standards to mitigate known hazards.
- Helps to understand the key concepts of Hazard, Hazardous situation, Harm, Risk, Residual Risk, especially that Risk Analysis is not the same as Risk Management.
