Device Software Development A Guide to Risk Management Requirements
Medical device risk management — specifically device software risk management — calls for a solid understanding of a myriad of requirements.
The FDA Quality Systems Regulation, ISO 14971, the new EU Medical Device Regulation all stress the importance of building risk management into the development process of software that will be used in or as a medical device.
Device Software Development — based on a presentation by quality systems expert Dan O’Leary — is a comprehensive, point-by-point guide to developing software that meets all FDA and international standards for successful market clearance. You’ll learn:
Which ISO standards touch on software development and risk management and what guidance is available
What requirements the new EU MDR places on software development
How to assess the level of a hazard’s severity
How to identify software’s safety classification
Pre- and postmarket risk management considerations
In addition to outlining effective risk management factors,the report includes the following downloadable tools:
510(k) Change Analysis Decision Flowcharts
Level of Concern Calculator
Software Safety Classification Guide
Device Software Development: A Guide to Risk Management Requirements shows you know what risk management methods and requirements you need to follow to get approval to market your device.
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PDF Edition — $397
Who Will Benefit
Software Quality Engineers
Risk Management Specialists
Regulatory Submission Specialists
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