|
Server : Apache/2.4.62 System : FreeBSD fbsdweb2.web.rcn.net 14.1-RELEASE FreeBSD 14.1-RELEASE releng/14.1-n267679-10e31f0946d8 GENERIC amd64 User : www ( 80) PHP Version : 8.3.8 Disable Function : NONE Directory : /domains/srakitin/ |
Upload File : |
<!DOCTYPE html PUBLIC "-//W3C//DTD XHTML 1.0 Transitional//EN" "http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd">
<html xmlns="http://www.w3.org/1999/xhtml">
<head>
<!-- Google tag (gtag.js) -->
<script async src="https://www.googletagmanager.com/gtag/js?id=G-PEGWQ57WKF"></script>
<script>
window.dataLayer = window.dataLayer || [];
function gtag(){dataLayer.push(arguments);}
gtag('js', new Date());
gtag('config', 'G-PEGWQ57WKF');
</script>
<meta http-equiv="Content-Type" content="text/html; charset=UTF-8" />
<title>Verification and Validation - Medical Device Industry</title>
<meta name="Keywords" content="Software Quality Consulting, safety critical, safety-critical, medical device, biotech, pharma, consulting, training, auditing, compliance, FDA, Design Controls, Verification, Validation, IEC 62304, ISO 14971, medical device manufacturer, software subcontractors, risk assessment, safety case,software, software quality, software quality assurance, software quality consulting, SQA, QA, QA Management, software management, software project management, software development management, process improvement, software process improvement, verification & validation, verification, validation, Independent Verification & Validation, IV&V, V&V, software V&V, software verification, software validation, test, testing, software testing, automated testing, test automation, testing tools, defects, bugs, embedded software, software requirements, writing requirements, writing software requirements, software inspections, inspections, formal inspection, Fagan Inspection, peer reviews, walkthrough, walkthru, software reliability, software safety, software risk management, medical device software, medical device software design, medical device software development. medical device software verification, medical device software validation, medical device software V&V, medical device V&V, FDA QSR, QSR, 21 CFR Part 11, Part 11, Computer System Validation, FDA Audit, FDA, medical software, process validation, compliance audit, clinical trial software, clinical trials data management software, device validation, design validation, design verification, software validation, validation audit, auditing, software audit, third party audit, due diligence, workshop, train, training, mentor, mentoring, facilitator, facilitating, coach, coaching, predictable software development, predictability, Configuration Management, CM, software standards, software metrics, software documents, retrospective, post-mortem, project retrospective, root cause analysis, software performance, safety-critical software, software quality consulting, Steven R. Rakitin, Steve Rakitin, Steven Rakitin, Rakitin"/>
<meta name="description" content="Verification and Validation - Medical Device Industry" />
<meta name="robots" content="index,follow" />
<link type="text/css" rel="stylesheet" href="normalizer.css" media="screen" />
<link type="text/css" rel="stylesheet" href="base.css" media="screen" />
<script type="text/javascript">
<!--
function MM_preloadImages() { //v3.0
var d=document; if(d.images){ if(!d.MM_p) d.MM_p=new Array();
var i,j=d.MM_p.length,a=MM_preloadImages.arguments; for(i=0; i<a.length; i++)
if (a[i].indexOf("#")!=0){ d.MM_p[j]=new Image; d.MM_p[j++].src=a[i];}}
}
function MM_swapImgRestore() { //v3.0
var i,x,a=document.MM_sr; for(i=0;a&&i<a.length&&(x=a[i])&&x.oSrc;i++) x.src=x.oSrc;
}
function MM_findObj(n, d) { //v4.01
var p,i,x; if(!d) d=document; if((p=n.indexOf("?"))>0&&parent.frames.length) {
d=parent.frames[n.substring(p+1)].document; n=n.substring(0,p);}
if(!(x=d[n])&&d.all) x=d.all[n]; for (i=0;!x&&i<d.forms.length;i++) x=d.forms[i][n];
for(i=0;!x&&d.layers&&i<d.layers.length;i++) x=MM_findObj(n,d.layers[i].document);
if(!x && d.getElementById) x=d.getElementById(n); return x;
}
function MM_swapImage() { //v3.0
var i,j=0,x,a=MM_swapImage.arguments; document.MM_sr=new Array; for(i=0;i<(a.length-2);i+=3)
if ((x=MM_findObj(a[i]))!=null){document.MM_sr[j++]=x; if(!x.oSrc) x.oSrc=x.src; x.src=a[i+2];}
}
//-->
</script>
<style type="text/css">
.nav {
height: 370px;
}
ul li {
list-style-type: disc;
}
.indent {
margin-left: 30px;
line-height: 27px;
list-style-type: disc;
}
.indent_white {
margin-left: 30px;
}
.white_bullet {
color: #fff;
}
.right {
margin-top: 90px;
}
</style>
</head>
<body onload="MM_preloadImages('images/nav_home_ACTIVE.gif','images/nav_about_ACTIVE.gif','images/nav_consulting_ACTIVE.gif','images/nav_training_ACTIVE.gif','images/nav_auditing_ACTIVE.gif','images/nav_sw_dev_ACTIVE.gif','images/nav_v_v_ACTIVE.gif','images/nav_contact_ACTIVE.gif','images/nav_med_industry_ACTIVE.gif','images/nav_nuc_industry_ACTIVE.gif','images/nav_transportation_ACTIVE.gif','images/nav_mission_critical_ACTIVE.gif')">
<div class="logo"><!--START LOGO-->
<a href="swqual.com"><img src="images/SQC_logo.jpg"/></a>
</div><!--END LOGO-->
<div class="container"><!--START CONTAINER-->
<div class="left"><!--START LEFT-->
<div class="nav"><!--START NAV-->
<ul>
<li><a href="index.html"><img src="images/nav_home.gif" alt="home" id="home" title="home"
onmouseover="MM_swapImage('home','','images/nav_home_ACTIVE.gif',1)" onmouseout="MM_swapImgRestore()" /></a></li>
<li><a href="about.html"><img src="images/nav_about.gif" alt="about" id="about" title="about"
onmouseover="MM_swapImage('about','','images/nav_about_ACTIVE.gif',1)" onmouseout="MM_swapImgRestore()" /></a></li>
<li><a href="consulting_medical.html"><img src="images/nav_consulting.gif" alt="consulting" id="consulting" title="consulting"
onmouseover="MM_swapImage('consulting','','images/nav_consulting_ACTIVE.gif',1)" onmouseout="MM_swapImgRestore()"/></a></li>
<li><a href="training_medical.html"><img src="images/nav_training.gif" alt="training" id="training" title="training"
onmouseover="MM_swapImage('training','','images/nav_training_ACTIVE.gif',1)" onmouseout="MM_swapImgRestore()"/></a></li>
<li><a href="auditing_medical.html"><img src="images/nav_auditing.gif" alt="auditing" id="auditing" title="auditing"
onmouseover="MM_swapImage('auditing','','images/nav_auditing_ACTIVE.gif',1)" onmouseout="MM_swapImgRestore()"/></a></li>
<!---
<li><a href="software_development.html"><img src="images/nav_sw_dev.gif" alt="software development" id="software development"
title="software development" onmouseover="MM_swapImage('software development','','images/nav_sw_dev_ACTIVE.gif',1)"
onmouseout="MM_swapImgRestore()"/></a></li>
<li><a href="verification_validation.html"><img src="images/nav_v_v_ACTIVE.gif" alt="verification and validation"
id="verification and validation" title="verification and validation"
onmouseover="MM_swapImage('verification and validation','','images/nav_v_v_ACTIVE.gif',1)"
onmouseout="MM_swapImgRestore()"/></a></li>
--->
<li><a href="verification_validation_medical.html"><img src="images/nav_v_v_ACTIVE.gif" alt="medical device industry"
id="medical device industry" title="medical device industry"
onmouseover="MM_swapImage('medical device industry','','images/nav_v_v_ACTIVE.gif',1)"
onmouseout="MM_swapImgRestore()"/></a></li>
<!---
<li><a href="verification_validation_nuclear.html"><img src="images/nav_nuc_industry.gif" alt="nuclear power industry"
id="nuclear power industry" title="nuclear power industry"
onmouseover="MM_swapImage('nuclear power industry','','images/nav_nuc_industry_ACTIVE.gif',1)"
onmouseout="MM_swapImgRestore()" /></a></li>
<li><a href="verification_validation_transportation.html"><img src="images/nav_transportation.gif" alt="transportation industry" id="transportation industry" title="transportation industry"
onmouseover="MM_swapImage('transportation industry','','images/nav_transportation_ACTIVE.gif',1)"
onmouseout="MM_swapImgRestore()" /></a></li>
<li><a href="verification_validation_mission.html"><img src="images/nav_mission_critical.gif" alt="mission-critical projects"
id="mission-critical projects" title="mission-critical projects"
onmouseover="MM_swapImage('mission-critical projects','','images/nav_mission_critical_ACTIVE.gif',1)"
onmouseout="MM_swapImgRestore()" /></a></li>
--->
<li><a href="contact.html"><img src="images/nav_contact.gif" alt="contact" id="contact" title="contact"
onmouseover="MM_swapImage('contact','','images/nav_contact_ACTIVE.gif',1)" onmouseout="MM_swapImgRestore()"/></a></li>
</ul>
</div><!--END NAV-->
<div class="content"><!--START CONTENT-->
<img src="images/Verification_validation.gif" alt="Verification and Validation header" title="Verification and Validation header"/>
<br/><br/>
<h1>Software V&V for the Medical Device Industry</h1>
Software V&V activities should be compliant with the FDA Guidance General Principles of Software Validation. This guidance recommends that the software development life cycle be fully integrated with risk management (ISO 14971) activities. Based on the intended use and the safety risk associated with the software to be developed, device manufacturers should determine the specific approach, the combination of techniques to be used, and the level of rigor that is appropriate. <br/><br/>
While the guidance does not endorse a specific software life cycle model, it does recommend that software validation and verification
activities be conducted throughout the entire software development life cycle. <br/><br/>
When software is developed by someone other than the device manufacturer (e.g., a third-party, or off-the-shelf software) the third party is often not directly responsible for compliance with FDA regulations. Device manufacturers need to assess the adequacy of the off-the-shelf software developer’s activities and determine what additional efforts (if any) are needed to establish that the software is appropriate for the device manufacturer’s intended use. Ultimately, the device manufacturer is responsible for all of the software embedded within medical devices that bear their company’s name. <br/><br/>
FDA defines software verification and software validation as follows:<br/><br/>
<b>Software verification</b> provides objective evidence that the design outputs of a particular phase of the software development life cycle meet all of the specified requirements for that phase. Software verification looks for consistency, completeness, and correctness of the software and its supporting documentation, as it is being developed, and provides support for a subsequent conclusion that software is validated.
<br/><br/>
<b>Software validation</b> is a part of the design validation for a finished device, but is not separately defined in the Quality System regulation. FDA considers software validation to be "confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled."
<br/><br/>
Understanding the essential principles of software verification and validation is critical for developing an integrated process that
addresses verification, validation and risk in a timely and cost-effective manner.<br/><br/>
I have over 35 years of experience performing software V&V and over 20 years working with software-based medical devices. During this time, I have helped dozens of device manufacturers successfully implement effective software V&V processes.<br/><br/>
Working collaboratively with your staff, we can develop cost-effective solutions that are fully compliant with applicable regulations and
guidance documents and at the same time, help your company achieve critical business objectives. <br/><br/>
</div><!--END CONTENT-->
</div><!--END LEFT-->
<div class="right"><!--START RIGHT-->
<br/><br/><br/><br/>
<a href="http://www.fda.gov"> <img src="images/FDA.gif" alt="FDA logo" title="FDA logo"/> </a><br/><br/><br/>
<a href="http://www.iso.org"> <img src="images/ISO.gif" alt="ISO logo" title="ISO logo"/> </a><br/><br/>
<a href="http://www.iec.org"> <img src="images/IEC.gif" alt="IEC logo" title="IEC logo"/> </a><br/><br/>
<br><br><br>
<a href="publications.html"> <img src="images/book_cover.jpg" alt="Software Verification and Validation for Practitioners and Managers" title="Software Verification and Validation for Practitioners and Managers"/> </a>
</div><!--END RIGHT-->
</div><!--END CONTAINER-->
<div class="footer"><!--START FOOTER-->
Food for Thought and Predictable Software Development are trademarks of Software Quality Consulting.<br/>
Copyright ©2025 Software Quality Consulting. All rights reserved.<br/>
Web Design: <a href="www.sarahcoledesign.com" target="blank">Sarah Cole Design</a>
</div><!--END FOOTER-->
</body>
</html>