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Article: Is software a medical device?(EURO NEWS)
- Article from:
- Medical Product Outsourcing
- Article date:
- June 1, 2007
- Author:
CopyrightCOPYRIGHT 2007 Rodman Publishing. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Recently, many clients have inquired if their software is considered a medical device. Therefore, it seems timely to answer this question. But first, let's start with a brief quiz. In each scenario below, would you consider the software a medical device?
1. Software used to plan cancer treatment doses and to control the setting of oncology treatment devices
2. Software used within the overall design and manufacturing processes of the medical devices
3. Software used to measure and calculate the anatomical sites of the body to facilitate the irradiation of surgical intervention
4. Software embedded in an implanted pulse generator device