This course will explain how to manage a design program that will meet FDA requirements and minimize chances of your medical device being recalled. The important and confusing question of when, in a development process, Design Control begins will be answered.

The differences between pre release and post release change control will be explained. The Design History File will be explained.  The interrelationship between ongoing risk analysis and the design process will be explained. The new Human Factors requirements will be discussed . Software validation, which is more than testing, will be explained.

Why Should You Attend:

Designing a medical device and testing it to prove it works is not sufficient in the eyes of the FDA to provide a safe product for users. The FDA has determined, through analysis of product recall data, that the majority of recalls were due to a faulty design process, not faulty manufacturing.

These recalled products were tested before release and later failed in unanticipated ways that were not considered in the design and testing process. FDA also concluded that a well controlled design process with risk analysis, change control, design reviews, hardware/ software validation, and human factors analysis will greatly reduce chances of an unsafe product.

Handouts are pre release change control form, post release change control form, user requirements template, DHF checklist

Course Objectives:

How to manage a Design Control program that will meet FDA requirements considering risk management, human factors and software validation.

Course Outline:

Session 1-Design Control

• Reasons for design control
• When design control begins
• Elements of a design control program
• How risk management fits into design control
• Change control
• Difference between verification and validation
• Understanding  validation consists of  more than testing
• Design History File
• Design transfer

Session2-Risk Management

• Explanation of the new ISO14971:2019
• Changes from the previous version
• Hazard analysis process with examples
• Explanation of “hazardous situation”, “ALARP”, “benefit/ risk ratio”, “residual risk” and other terms
• Post production requirements will be explained

Session3-Human Factors Analysis

• Shift in responsibility for errors to the designer
• FDA Guidance and ISO 62366 explained
• Use scenarios, Tasks and other terms explained with examples
• Analysis as part of the design process explained
• How to conduct a Human Factors Validation

Session4-Software Validation

• How software validation is more than testing
• Software validation process
• Requirements traceability
• Software risk analysis
• Configuration management

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Engineering personnel
• Software developers
• Development Engineers
• Production Management
• QA/ QC personnel
• Management