Medical Device Hazard Analysis following ISO 14971
Ed retired from industry after 27 years in management of development of medical device products and development of company Quality Systems. He has been a consultant for the last10 years, working with companies from startups to Fortune 100 in the US, Germany, United Kingdom, Netherlands, Canada, Poland, and Saudi Arabia. He specializes in design control, risk analysis, human factors, software validation, cybersecurity and supplier qualification/ control. Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects a post-production risk management program to be implemented. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard.
One of the techniques described in ISO 14971 is Hazard Analysis. This is the most powerful of the risk management techniques because it considers risks in normal operation as well as fault conditions. FMEA and FTA consider only fault conditions and are more suited as reliability tools than as product safety tools.
In this Webinar, we will explain in detail the process of conducting a hazard analysis. The confusing terms “hazard”, hazardous situation”, “harm”, “causative event”, “ALARP”, “risk index”, “benefit/ risk ratio”, and “residual risk” will be explained. We will go step by step through a template for risk analysis so that the process is clear. Examples of hazards and hazardous situations will be discussed. How to deal with residual risk will be discussed.
We will explain how to integrate Human Factors studies into the Hazard Analysis and how to integrate Hazard Analysis into the design program. Risk level can determine the extent of CAPA investigations, validation effort, etc. The application of ISO 14971 principles to software risk management will be explained.
Explanation of Hazard Analysis terms: hazard, hazardous situation, harm, risk explanation of the hazard analysis process using template examples of terms will be given hazard analysis examples will be covered step by step.
Course Level - Intermediate
Who Should Attend
- Engineering Manager
- Regulatory Personnel
Why Should You Attend
FDA expects that as part of a product development program risk management will be conducted and risks will be mitigated as far as practical. Risk Analysis is required in an FDA product submission. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. Hazard Analysis is the most powerful of the risk management tools described in ISO 14971 but it is very confusing. Many new concepts are introduced. We will explain these concepts and provide examples so that the process is clear. Handouts are hazard analysis forms and the HA report template.