• Brian Shoemaker Recorded
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    Duration:90 Minutes
    Price: $190.00
    by: Brian Shoemaker
    Standards for Medical Device Software: Friend, not Foe
    With various changes to standards and regulations, it is important to understand the criteria for compliance, this is your DIY guide to the changes in standards, specifically covering the IEC 62304 standard.

  • Brian Shoemaker Recorded
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    Duration:90 Minutes
    Price: $190.00
    by: Brian Shoemaker
    Agile for Medical Devices: More than Just Software
    Trying to understand the "Agile method" as just another software development lifecycle, with specific rules and a fixed outline, is mistaken, and seriously limits the benefits that Agile can bring. Successful Agile implementations include development, operations and business functions right from the outset. Anything less just creates another process island and cross function friction. All functions must participate actively throughout development, since development is recognized to require learning and adapting (and market needs can change rapidly).

  • Brian Shoemaker Recorded
    View Anytime
    Duration:90 Minutes
    Price: $190.00
    by: Brian Shoemaker
    Implementing Agile in an FDA-Regulated Environment
    The Agile approach is well established in other industries adoption of Agile in medical device development has been increasing in the past five years. Experience is showing that both quality and safety are improved when the development team is agile, and that regulatory requirements can still be met. This session will delve into several key areas for applying Agile in the medical device context, including:

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