How to Meet Regulatory Expectations for SaMD

    Leveraging these expectations to ensure the highest level of quality for your Software as a Medical Device (SaMD)
    Read more

    5 Easy Steps for SaMD Startups to Successfully Implement a QMS

    Learn about setting up a QMS for Software as a Medical Device (SaMD), from planning, documentation, implementation, to control.
    Read more

    Architecting Atlassian for Healthcare and FDA Compliance: Part 2

    Using Atlassian’s Jira framework to transform and boost DevOps!
    Read more

    Architecting Atlassian for Healthcare and FDA Compliance: Part 1

    Bridging the gap between agile development for innovation and audit readiness for compliance!
    Read more

    6 Steps for Implementing a QMS Software

    Learn the right steps to adopting an eQMS for your Medical Device or Life Science organization.
    Read more

    What Atlassian's Elimination of Jira Server Means For Your Business

    How the transition from Jira Server to Jira Cloud will impact Healthcare and Life Science Companies
    Read more

    A Simple Breakdown of ISO and IEC Standards for SaMD

    Understanding the difference and benefits between ISO and IEC Standards for Software as a Medical Device
    Read more

    Crucial Do’s and Don’ts of SaMD Development

    Explore the unique challenges and considerations of SaMD development.
    Read more

    Using Agile in SaMD Development Under IEC 62304

    Uncovering how Agile practices fulfill Software as a Medical Device (SaMD) Development
    Read more

    What is FDA's 21 CFR Part 820?

    Unpacking the FDA guidelines and regulations under 21 CFR Part 820.
    Read more

    Recent Posts

    Topics

    See all

    Subscribe Here