Keeping a pulse on current risk management standards, adhering to industry requirements, and understanding how to utilize risk management to inform business decisions are some of the most important things you can do as a medical device professional.
Yet Greenlight Guru’s 2023 Industry Benchmark Survey found that these are still major challenges.
As leader in the medical industry, we’re proud to join Greenlight Guru and speak on this important topic. Our expert in Risk Management, Asra Saleh, will do a full session and Q&A on How Usability Brings Value to Risk Controls.
Do it by Design: How Usability Brings Value to Risk Controls
Use-errors accounts for the majority of medical devices incident reports. Additionally, according to the World Health Organization, it was also reported that the design of a medical device is often inappropriate for the context in which it is used.
Therefore, it is crucial to pay more attention to usability and human factors during medical device development. A strong usability engineering methodology that complies with international standards is needed to address this problem.
To control use-related risks, the usability engineer should ‘design for risk control’ in a structured manner, while the risk manager should remain responsible for acceptable levels of residual risk. However, most companies frequently fail to put such a procedure into practice, which impedes the enhancement of usability and consequently increases the danger of errors.
In addition to our session, you’ll gain valuable insights, best practices, and practical tips that will empower you to mitigate risks and ensure compliance within your organization.
- Understand what medical device regulators expect in regard to Risk Management
- Implement ISO 14971 guidelines and best practices effectively
- Understand HOW you should be doing risk management (not just the requirements)
- Apply a risk-based approach to all QMS processes
The summit is 100% virtual and 100% free. You won’t wanna miss it!
