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 you should 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.
Learning Objectives:
How to manage a Design Control program that will meet FDA requirements considering risk management, human factors and software validation.
Who Will Benefit
Why you should 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.
Learning Objectives:
How to manage a Design Control program that will meet FDA requirements considering risk management, human factors and software validation.
Who Will Benefit
- Engineering Personnel
- Software Developers
- Development Engineers
- Production Management
- QA/QC Personnel
- Management
Agenda
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
Session 2-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
Speaker
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 US and internationally 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.Who Should Attend
- Engineering Personnel
- Software Developers
- Development Engineers
- Production Management
- QA/ QC Personnel
- Management
