Medical Device Risk Management Following ISO 14971:2019
Edwin Waldbusser is a consultant retired from the
industry after 20 years in management of the development of medical
devices (5 patents). He has been consulting in the US and
internationally in the areas of design control, risk analysis and
software validation for the past 8 years. Mr. Waldbusser has a BS in
Mechanical Engineering and an MBA. He is a Lloyds of London certified
ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects that a post-production risk management program is implemented. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. Hazard Analysis is described in ISO 14971. 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, validations effort, etc. Application of ISO 14971 principles to software risk management will be explained. Requirements for each step of the risk management process, including the risk management plan, development of risk acceptability criteria, risk analysis, risk evaluation, risk control, risk/ benefit analysis, postproduction analysis will be explained.
- Explanation of Hazard Analysis terms: hazard, hazardous situation, harm, risk, acceptability criteria, benefit/ risk ratio
- Explanation of the hazard analysis process using a template
- Examples of terms will be given
- Hazard analysis examples will be covered step by step
- Risk management plan
- Risk management file
Course Level - Basic and Intermediate
Who Should Attend
- Engineering Manager
- Manufacturing 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, described in ISO 14971, is the most powerful of the risk management tools, but it is very confusing. Many new concepts are introduced. We will explain these concepts and provide examples so that you can expertly perform the process. Templates will be provided. Handouts are hazard analysis forms and the HA report template.
A new version of ISO14971 has been issued containing many important changes to risk management. US FDA accepts this document and expects companies to conform to its requirements.