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Software design for_medical_devices_europe_conferent_19012011[1]

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Erik Vollebregt
Erik Vollebregt

Presentation at the Software Development for Medical Devices Eru

Salud y medicina
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Legal aspects of medical devices software and software as medical device 19 January 2011 ©2007, Greenberg Traurig, LLP. Attorneys at Law. All rights reserved. GREENBERG TRAURIG, LLP ▪ ATTORNEYS AT LAW ▪ WWW.GTLAW.COM Software Design for Medical Devices EUROPE
Overview ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Developments ,[object Object],[object Object],[object Object],[object Object]
Developments ,[object Object],[object Object]
Developments ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Software in and as medical device ,[object Object],[object Object],[object Object],[object Object]
When is software a medical device? ,[object Object],[object Object],[object Object],[object Object]
When is software a medical device? ,[object Object],[object Object],[object Object],[object Object]
When must software be CE-marked? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
When must software be CE-marked? ,[object Object],[object Object],[object Object],[object Object],[object Object]
Changes with respect to software ,[object Object],[object Object],[object Object],[object Object],[object Object]
Classification ,[object Object],[object Object],[object Object],[object Object],[object Object]
Manufacturer obligations ,[object Object],[object Object],[object Object],[object Object],[object Object]
Manufacturer obligations : comply with CE ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Subcontractors for software ,[object Object],[object Object]
Subcontractors for software ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Standards and guidance ,[object Object],[object Object],[object Object],[object Object]
Standards and guidance ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Standards and guidance ,[object Object],[object Object],[object Object],[object Object],[object Object]
IEC 62304 - Relationship to other standards
Clinical Evaluation of Software ,[object Object],[object Object],[object Object],[object Object],[object Object]
Clinical Evaluation of Software ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Clinical Investigation of Software ,[object Object],[object Object],[object Object],[object Object],[object Object]
Installation and Maintenance in Networks ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Installation and Maintenance in Networks ,[object Object],[object Object],[object Object],[object Object]
Installation and Maintenance in Networks ,[object Object],[object Object],[object Object],[object Object]
Installation and Maintenance in Networks ,[object Object],[object Object],[object Object],[object Object],[object Object]
What is next in regulatory re software? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Erik Vollebregt ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

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Software design for_medical_devices_europe_conferent_19012011[1]

  • 1. Legal aspects of medical devices software and software as medical device 19 January 2011 ©2007, Greenberg Traurig, LLP. Attorneys at Law. All rights reserved. GREENBERG TRAURIG, LLP ▪ ATTORNEYS AT LAW ▪ WWW.GTLAW.COM Software Design for Medical Devices EUROPE
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  • 20. IEC 62304 - Relationship to other standards
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