ISO 14971:
Creating & Implementing a PHA
A Hands-On Workshop with Dr. Naveen Agarwal
Feedback from past workshop attendee:
“I really enjoyed the workshop and learned a lot from it. I am going to suggest we implement the PHA, as it is a very useful tool and I think it will help with our risk management process.”
-Regulatory Affairs Manager
Learning Objectives
.01
Understand key elements of a Preliminary Hazard Analysis (PHA) and how it can help you meet requirements of ISO 14971:2019
.02
Understand basic terms and their application in analyzing medical device risks
.03
Understand how to estimate and evaluate risk
.04
Practice developing a PHA in hands-on breakout sessions
.05
Review a PHA template with an option to extend it into a risk assessment
This workshop is perfect for:
Design Quality Engineers
Product Quality Engineers
Quality Managers
Risk Managers
Product Developers
Product Engineers
Regulatory Affairs Managers
Medical Safety Officers
You will receive:
Certificate of completion
Workshop slides
Breakout session slides and worksheet
PHA worksheet template
