VxWorks cert edition is now IEC 62304 compliant
Summary
To aid in these efforts, Wind River has just announced that the VxWorks cert edition product has achieved IEC 62304 medical standard compliance. Regulatory agencies, such as the FDA (Food and Drug Administration) in North America, or the EMA (European Medicines Agency) in Europe, have enlisted IEC 62304 among the harmonised standards whose compliance with would make it easier to get regulatory approval to sell and operate medical devices. The answer is to be found in the critical role that software, and in particular the operating system, plays in medical device development. Using VxWorks as a component in a medical device reduces, or in some cases, even eliminates the manufacturer having to validate the OS using Software of Unknown Provenance (SOUP). This makes the tradeoff between time, cost, quality and regulatory mandates a little bit easier since the OS has been designed and tested with Medical standards in mind.
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