{"id":3579,"date":"2021-05-17T20:24:23","date_gmt":"2021-05-17T13:24:23","guid":{"rendered":"https:\/\/www.squat.in.th\/en\/?p=3579"},"modified":"2025-10-22T21:25:14","modified_gmt":"2025-10-22T14:25:14","slug":"mds-vv-ep2","status":"publish","type":"post","link":"https:\/\/www.squat.in.th\/en\/mds-vv-ep2\/","title":{"rendered":"Medical Device Software Standards (Part 2)"},"content":{"rendered":"\t\t
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Software Quality Management: Building Reliable and Safe Medical Software<\/span><\/strong><\/span><\/p>

Software quality management<\/strong> plays a vital role in ensuring that medical device software meets user needs, functions reliably, and maintains patient safety.
Poor-quality software can arise from several causes \u2014 for example:<\/p>

  • The software meets user requirements but is not cost-effective<\/strong>.<\/li>
  • The software is reasonably priced but does not meet user needs<\/strong>.<\/li>
  • The software is affordable and functional but unreliable and prone to frequent failures<\/strong>.<\/li><\/ul>

    These examples highlight that focusing on only one or two aspects of quality \u2014 such as cost or functionality \u2014 without considering all dimensions leads to imbalance.
    To achieve truly high-quality software, it is essential to address all three quality perspectives<\/strong>:<\/p>

    1. User\u2019s perspective<\/strong><\/li>
    2. Developer\u2019s perspective<\/strong><\/li>
    3. Product\u2019s perspective<\/strong> \u2014 the software itself<\/li><\/ol>

      [\"\"\u00a0<\/p>

      Figure 4<\/i>
      <\/span><\/b><\/p>

      The Quality Triangle<\/span><\/b><\/p>

      \u00a0<\/p>

      The relationship between these three viewpoints can be represented as the\u00a0Quality Triangle<\/b>.
      Each corner of the triangle corresponds to one perspective \u2014 the\u00a0User\u2019s View<\/b>,\u00a0Manufacturer\u2019s View<\/b>, and\u00a0Product\u2019s View<\/b>\u00a0\u2014 while the sides represent the\u00a0gaps<\/b>\u00a0or differences between them.<\/span><\/p>

      • When the three perspectives are\u00a0misaligned<\/b>, the triangle becomes large, indicating wide gaps in understanding or expectations.<\/span><\/li>
      • When they are\u00a0aligned<\/b>, the triangle shrinks, reflecting better balance and shared understanding.<\/span><\/li>
      • Ideally, when all three converge perfectly, the triangle collapses into a\u00a0single point<\/b>, symbolizing full harmony between user needs, product design, and developer intent.<\/span><\/li><\/ul>

        The ultimate goal of software quality management is to\u00a0minimize the size of this triangle<\/b>\u00a0\u2014 aligning perspectives to deliver software that precisely meets user expectations.<\/span><\/p>

        \u00a0<\/p>

        <\/div>

        Software Verification and Validation (V&V)<\/span><\/b><\/p>

        Software Verification and Validation (V&V)<\/span><\/b>\u00a0are essential processes for confirming that a software system performs according to its intended requirements and design.
        Their main objective is to identify and correct\u00a0defects, errors, and failures<\/b>\u00a0in the system.<\/span><\/p>

        V&V activities are fundamental to\u00a0Quality Assurance (QA)<\/b>\u00a0\u2014 providing measurable improvement \u2014 and part of\u00a0Quality Control (QC)<\/b>, ensuring testing outcomes meet defined standards.<\/span><\/p>

        Software Validation<\/span><\/b><\/p>

        Validation ensures that the final software product meets\u00a0user requirements<\/b>\u00a0and performs as expected in real-world use.
        It represents the\u00a0external quality perspective<\/b>, asking the question:<\/span><\/p>

        \u201cHave we built the right product?\u201d<\/span><\/p>

        When achieved, this results in a\u00a0Good Product<\/b>.<\/span><\/p>

        Software Verification<\/span><\/b><\/p>

        Verification ensures that the software correctly implements the\u00a0design specifications<\/b>\u00a0and that each component functions as intended.
        It represents the\u00a0internal quality perspective<\/b>, asking:<\/span><\/p>

        \u201cHave we built the product right?\u201d<\/span><\/p>

        This results in a\u00a0Good Process<\/b>.<\/span><\/p>

        Together,\u00a0Verification and Validation<\/b>\u00a0build confidence that both the process and product achieve the highest quality standards.<\/span><\/p>

        \u00a0<\/p>

        <\/div>

        Common V&V Techniques<\/span><\/b><\/p>

        The two most widely used V&V techniques are\u00a0Review<\/b>\u00a0and\u00a0Testing<\/b>:<\/span><\/p>

        • Review techniques<\/span><\/b>\u00a0are\u00a0preventive<\/i>, aiming to identify potential issues before the software is executed.<\/span><\/li>
        • Testing techniques<\/span><\/b>\u00a0are\u00a0corrective<\/i>, used to detect and fix errors after code execution.<\/span><\/li><\/ul>