Medical Device Risk Management following ISO 14971:2019

Product Id : PE237
Instructor : Edwin Waldbusser
Apr 15, 2020 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes


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 a 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.

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 be 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 Edwin 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. 

Edwin 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.

Areas Covered in the Session:

  • 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

Who will benefit:

  • Engineer
  • Engineering Manager
  • Manufacturing manager
  • Regulatory Personnel
  • QA
Speaker Profile:

Edwin Waldbusser is a Regulatory Consultant at Medical Device Advisors. He is holder of BSc. Mechanical Engineering and Master in Business Administration.

After more than 20 year of work and retirement from management of medical devices development (5 patents), Mr. Waldbusser is now a highly experienced consultant. He has been a consultant in the fields of risk analysis, software validation and design control for 8 years now.

Mr. Waldbusser is a Lloyds of London ISO 9000 Lead Auditor. He is also a board member of Thomson Reuter Expert Witness network.

Available Options