Top 3 Requirements for Software as  Medical Device (SaMD)

    A deeper dive into crucial policies for Software for Medical Device (SaMD) Organizations
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    The Ultimate Quality Management System for Life Sciences

    Must-Have Features & Functionality for Your Quality Management System (QMS)
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    Using Agile in SaMD Development Under IEC 62304

    Uncovering how Agile practices fulfill Software as a Medical Device (SaMD) Development
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    What is FDA's 21 CFR Part 820?

    Unpacking the FDA guidelines and regulations under 21 CFR Part 820.
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    The Ultimate SaMD Development Plan

    Easy ways to meet FDA Regulatory Requirements with your Software Development Plan
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    What is ISO 13485:2016?

    An easily digestible overview of ISO 13485 and how it applies to your medical device company.
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    Medical Device Single Audit Program (MDSAP) Explained

    A simple breakdown of MDSAP, how it can benefit your company, and detailed instructions on how to get started.
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    ISO 13485 - Regulatory Requirements on Medical Devices

    How embracing regulations can give you a leg up on your competition.
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    Medical Device Software & SaMDs: A Crash Course

    A quick and easy rundown of ISO and IEC standards. 
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    New Medical Device & Life Science Collaboration Platform

    Sierra Policies Quick Start video out now!
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