Medical Devices by their very nature must be safe for human use and must meet the requirements for which they have been designed. The process that identifies the risks associated with a medical device that could make the device unsafe or not function as intended is called Risk/Hazard Analysis.
21 CFR Section 820 requires that comprehensive risk analysis be performed as part of the medical device regulatory submissions process and throughout the product’s lifecycle. ISO 14971 is the risk management standard for medical devices. Its purpose is to help manufacturers establish a risk management process that can be used to identify hazards, estimate and evaluate risks, and develop, implement, and monitor the effectiveness of risk control measures. This webinar will discuss both the regulatory requirements and the process for conducting effective Risk/Hazard Analysis.
WHY SHOULD YOU ATTEND?
The secret to preventing medical device recalls or at least minimizing their impact is sound Risk/Hazard Analysis. Aside from being required, it is absolutely essential and necessary to the development and fielding of medical devices that offer a significant level of protection for patients and manufacturers alike.
The seminar will explore the basic principles of risk management and planning as they relate to medical device design and as required by the FDA. It will present a logical process for risk management from risk identification through evaluation/rating and mitigation.
The tools and techniques of Risk Analysis and the rating process used to evaluate the risks identified will be presented and discussed – Fault Tree Analysis, Failure Mode Effects Analysis, and Failure Mode Effects and Criticality Analysis.
LEARNING OBJECTIVES
- Why Risk/Hazard Analysis is important
- Risk Assessment Defined
- Regulatory Requirements
- Risk Management Process – The Risk Management Plan
- Risk Management Documentation
- Risk Analysis Processes and Techniques
- Asking the Right Questions
- The Evaluation/Analysis Tools – FTA, FMEA, and FMECA
- Risk Control/Mitigation
WHO WILL BENEFIT?
- Medical Device Engineers
- Scientists
- Design Engineers,
- Regulatory Associates Etc.
- Managers,
- Associate Directors,
- Directors and Associates of all levels
The secret to preventing medical device recalls or at least minimizing their impact is sound Risk/Hazard Analysis. Aside from being required, it is absolutely essential and necessary to the development and fielding of medical devices that offer a significant level of protection for patients and manufacturers alike.
The seminar will explore the basic principles of risk management and planning as they relate to medical device design and as required by the FDA. It will present a logical process for risk management from risk identification through evaluation/rating and mitigation.
The tools and techniques of Risk Analysis and the rating process used to evaluate the risks identified will be presented and discussed – Fault Tree Analysis, Failure Mode Effects Analysis, and Failure Mode Effects and Criticality Analysis.
- Why Risk/Hazard Analysis is important
- Risk Assessment Defined
- Regulatory Requirements
- Risk Management Process – The Risk Management Plan
- Risk Management Documentation
- Risk Analysis Processes and Techniques
- Asking the Right Questions
- The Evaluation/Analysis Tools – FTA, FMEA, and FMECA
- Risk Control/Mitigation
- Medical Device Engineers
- Scientists
- Design Engineers,
- Regulatory Associates Etc.
- Managers,
- Associate Directors,
- Directors and Associates of all levels
Speaker Profile

Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer, and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars on a variety of related subjects from documentation development to establishing compliant preventive maintenance systems.
Upcoming Webinars

Interactive dashboards & analytics in Excel

Copilot and HR: An Introduction for HR Professionals

4-Hour Virtual Seminar on Bootcamp on Excel

Leading Across Generations: 5 Challenges & 10 Strategies to…


I-9 Audits: Strengthening Your Immigration Compliance Strat…

Fair Lending in 2025: New Regulations, Examinations and Enf…


Tattoos, hijabs, piercings, and pink hair: The challenges …

Using Emotional Intelligence to Elevate Your Leadership

ChatGPT & HR: How HR Recruiting Professionals Can Leverage …

FDA Trends in Compliance and Enforcement in Computer System…

Elevate Your Workplace Wellness: 10 Critical Wellness Facto…

How to Manage the Legal Landmine of the FMLA, ADA and Worke…

How to Write a Successful Job Hazard Analysis


How to Write Right for Better Business Communication

How to Prepare For and Host a FDA Inspection and Respond to…

Public Speaking: Overcoming The Fear of Public Speaking

From Good to Great: The Secrets to an Optimized LinkedIn Pr…



Workplace Investigations 101: How to Conduct your Investiga…

Policy Pops: Navigating DEI in the 2025 Workplace: Strategi…

The Five Cs Of Commercial Credit: The Basic Elements Of Cre…

Transforming Anger And Conflict Into Collaborative Problem …


Navigating Alcohol and Drug Addiction Protections Under the…


Reduce Stress in the Workplace: Effective Ways to Handle Co…



Transforming HR with AI: Unlocking Excellence and Innovation

Creating Employee Handbooks that Protect You and Support th…

FDA Technology Modernization Action Plan (TMAP) and Impact …


Transform Data into Insights: A Beginners Guide to Excel Pi…


Mindful Communication:The Key to Meaningful Conversations i…

FDA Proposes Framework to Advance Credibility of AI Models

50+ new Excel features so far this decade

FMLA Compliance in 2025: A Comprehensive Guide & Strategies…

Excel - 10 Key Worksheet Functions to Skyrocket Your Produc…

Managing Toxic Employees: Strategies For Leaders To Effecti…

Hiring and Retaining Employees in this Crazy Economy

Harassment, Bullying, Gossip, Confrontational and Disruptiv…