of 38
All materials on our website are shared by users. If you have any questions about copyright issues, please report us to resolve them. We are always happy to assist you.

Intro to IEC62304 - Software Life Cycle for Medical Devices

Category:

Documents

Publish on:

Views: 60 | Pages: 38

Extension: PDF | Download: 0

Share
Description
Navigation Introduction into IEC 62304 Software life cycle for medical devices Christoph Gerber 4. September 2008 SPIQ 9/5/2008 1 Navigation Agenda Current Picture Regulatory requirements for medical device software IEC 62304 Overview IEC 62304 Key concepts Summary References Q&A Navigation Current Picture Navigation Current picture in medical device industry Dramatic increase in compliance and regulatory requirements Diverse regulatory requirements for different countries Increased
Transcript
  9/5/20081 Navigation Introduction into IEC 62304Software life cycle for medical devices Christoph Gerber4. September 2008SPIQ  Navigation Agenda  Current Picture  Regulatory requirements for medical device software  IEC 62304 Overview  IEC 62304 Key concepts  Summary  References  Q&A  Navigation Current Picture  Navigation Current picture in medical device industry  Dramatic increase in compliance and regulatory requirements  Diverse regulatory requirements for different countries  Increased number of recent recalls were software related  Increasing number of medical devices which are pure SW products  FDA raises expectation on software testing methodologies  Opinion that software development in medical device industry isbehind other mission critical industries such as aviation  For vendor: No choice be compliant! 
Tags
Search Related
We Need Your Support
Thank you for visiting our website and your interest in our free products and services. We are nonprofit website to share and download documents. To the running of this website, we need your help to support us.

Thanks to everyone for your continued support.

No, Thanks