The Growing Importance of Software in FDA-Regulated Medical Devices
How Medical Device Makers Can Meet Safety Requirements, Cut Development
Costs, and Achieve Time to Market Using Off-the-Shelf Solutions
This web seminar series provides a lifecycle view of software safety and the regulation of medical devices by the Food and Drug Administration (FDA). A discussion of the concepts, definitions and important points of the FDA requirements is provided. The medical device development lifecycle is described in the context of FDA regulation and other applicable software safety standards such as IEC 61508 and 62304. The web seminar will also include a discussion of FDAâ€™s enforcement process, including inspections and product recalls, and recent enforcement action relating to medical device software.
The use of Commercial Off The Shelf (COTS) hardware and software is important for medical device manufacturers. Building customer-specific hardware and writing unique software for each device can expensive and inefficient. By leveraging COTS, medical device companies can decrease certification and development time and dedicate more time to product quality and differentiating features. The webinar will explain how Wind Riverâ€™s COTS solutions and technology platforms can be integrated into safety-critical medical device development processes.
Part 1: Safety First Â Â Â Â Â Â Â Sep 23, 2010 – 11:00am PDT
The first webinar introduces the current state of medical software safety and FDAâ€™s increasing interest in software safety.
Part 2: The Regulatory Lifecycle Â Oct 20, 2010 – 11:00am PDT
The second webinar goes into more detail on the medical device regulatory lifecycle. Risk management is a guiding principle in software safety, and COTS software solutions are introduced as a way to decrease product development costs and product safety risks.
Part 3: Risk Mitigation Â Â Â Â Â Â Â Nov 17, 2010 – 11:00am PDT
The third and final webinar describes what happens when a facility is inspected and how to mitigate the risk of a device recall during the development of the medical device. The focus will be on inspection preparedness, including a review of recent inspections and recalls involving medical device software, and the consequences of not following proper processes and procedures.
- ALLISON FULTON Associate in the Food and Drug Practice, Sidley Austin, LLP
- BILL GRAHAM Â Product Marketing Manager for VxWorks, Â Â Wind River
- RICHARD NASS Director of Content, Medical Devices Group,Canon Comm. LLP