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 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 seminar 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.
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 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 HA report template.
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 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 HA report template.
Edwin Waldbusser
Edwin Waldbusser, is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting 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 network.
HIPAA Compliance in 2026 — Practical Strategies for Breach …
Launch Your Career: The Ultimate Guide for Emerging Profess…
Moving From an Operational Manager to a Strategic Leader
Discover how Emotional Intelligence turns AI from a technic…
Dealing With Difficult People: At Work & In Life
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Empowering Conflict Resolution: Letting Go to Gain Control
The 60 Minutes Introduction to DAX
The 6 Most Common Problems in FDA Software Validation and V…
High-Impact Performance Management: Tools, Tactics & Coachi…
AI Across the Business: Practical Use Cases for Founders an…
Faster, Better Talent Acquisition: Leveraging AI & ChatGPT …
The Anti-Kickback Statute: Enforcement and Recent Updates
Do's and Don'ts of Giving Effective Feedback for Performanc…
Emotional Intelligence: Mastering the Emotions of Great Lea…
Copilot and HR: An Introduction for HR Professionals
Goal Mastery: From Resolutions to Results in 2026
Your AI Advantage: How HR Professionals Can Use Claude to S…
Human Error Reduction Techniques for Floor Supervisors
Validation of FDA-Regulated Medical Device and SaMD Product…
Human Factors Usability Studies Following ISO 62366 and FDA…
Managing Toxic & Other Employees Who Have Attitude Issues
I-9 Enforcement & Compliance: A 5-Step Plan for Employers t…
Major cGMP Issues: FDA Concerns in 2026
4-Hour Virtual Seminar on Transformational Leadership - The…
Understanding EBITDA – Definition, Formula & Calculation
DOL Reverses Course on Independent Contractor Rule for 2026…
Managing Toxic Employees: Strategies For Leaders To Effecti…
ChatGPT and Project Management: Leveraging AI for Project M…
Navigating HR Like A Pro: What Every Small Business & New H…
HPLC Analytical Method Development and Validation
Negotiating Skills For Professional Results - Winning Strat…
Managing Projects When AI Joins the Team: Human Judgment, A…
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Paying and Receiving Payments for Referrals: You Can Go to …
Ten Red Flags that Signal Financial Distress in Business Cu…
The Age-Inclusive Workplace: How to Lead and Work Across Ge…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Fatal Errors Employers Make When Updating Employee Handbook…
AI Fundamentals for All Leaders and Managers: How to Work S…