|
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 Regulations</title>
<meta name="Keywords" content="Software Quality Consulting, 21 CFR 820, QSR, GMP, premarket submission, software contained in medical devices, software validation, off-the-shelf, medical devices, computerized systems, clinical trials, Part 11, 21 CFR Part 11, electronic records, electronic signatures, networked medical devices, defective software, Therac-25" />
<meta name="description" content="Verification and Validation - Medical Device Regulations" />
<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_white {
margin-left: 30px;
}
.white_bullet {
color: #fff;
}
.indent {
margin-left: 30px;
line-height: 27px;
}
.right {
margin-top: 90px;
}
.FDA_logo {
float: right;
height: 65px;
width: 145px;
}
</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.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.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.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_med_industry_ACTIVE.gif" alt="medical device industry"
id="medical device industry" title="medical device industry"
onmouseover="MM_swapImage('medical device industry','','images/nav_med_industry_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/>
<a href="verification_validation_medical.html"><img src="images/arrow_back.gif" />
back to Verification & Validation Services for the Medical Device Industry
</a><br/><br/>
<h1>Selected FDA regulations, guidance documents and articles</h1>
Selected references from FDA are listed below.
These are available from <a href="http://www.fda.gov/MedicalDevices/default.htm" target="blank" >FDA.gov</a> or you can click on a document below to download a PDF version. <br/><br/>
<span class="bold">Regulations </span><br/><br/>
<ul class="indent_white">
<li><a href="images/QSR.pdf">21 CFR 820, Current GMP, Final Rule, October 7, 1996 FDA.</a> </li>
<li class="white_bullet"></li>
<li><a href="images/Part11.pdf">21 CFR Part 11, Electronic Records Electronic Signatures, Final Rule, March 20,
1997 FDA.</a></li>
</ul><br/>
<span class="bold">Guidance Documents</span><br/><br/>
<ul class="indent_white">
<li><a href="images/premarket.pdf">Guidance for the Content of Premarket Submission for Software Contained in Medical Devices,
May 11, 2005 CDRH, CBER. </a></li>
<li class="white_bullet"></li>
<li><a href="images/GPSV.pdf">General Principles of Software Validation, FINAL Guidance, dated January 11,
2002 CDRH.</a></li>
<li class="white_bullet"></li>
<li><a href="images/ots.pdf">Guidance for Off-the-Shelf Software Use in Medical Devices, Draft Guidance,
dated August 17, 1998 ODE. </a></li>
<li class="white_bullet"></li>
<li><a href="images/trials.pdf">Guidance for Industry Computerized Systems Used in Clinical Trials, Sept 2004 FDA. </a></li>
<li class="white_bullet"></li>
<li><a href="images/510k_1.pdf">Guidance for the Content of Pre-market Submission for Medical Devices Containing Software,
Final, May 29, 1998 ODE. </a></li>
<li class="white_bullet"></li>
<li><a href="images/design.pdf">Design Control Guidance for Medical Device Manufacturers, dated March 11, 1997 CDRH.</a></li>
<li class="white_bullet"></li>
<li><a href="images/Humanfactors.pdf">Do It By Design, A Guide to Human Factors in Medical Device Design, January 1997
FDA. </a></li>
</ul><br/>
<span class="bold">Part 11 Guidance Documents </span><br/><br/>
<ul class="indent_white">
<li><a href="images/premarket.pdf">Guidance for Industry, 21 CFR Part 11 Electronic Records Electronic Signatures; Scope and Application, Draft, February 2003 FDA.</a></li>
</ul><br/>
<span class="bold">Articles </span><br/><br/>
<ul class="indent_white">
<li><a href="images/Networked.pdf">"Networked Medical Devices: Essential Collaboration for Improved Safety"</a>,
by Steven R. Rakitin, AAMI BI&T, Vol. 43, No. 4, July-Aug 2009, p.332-338. </li>
<li class="white_bullet"></li>
<li><a href="images/Coping.pdf">"Coping with Defective Software in Medical Devices"</a>, by Steven R. Rakitin,
IEEE Computer, April 2006. </li>
<li class="white_bullet"></li>
<li><a href="images/Therac25.pdf">"An Investigation of the Therac-25 Accidents"</a>, by Nancy Leveson and
Clark Turner, IEEE Computer, July 1993. </li>
</ul>
</div><!--END CONTENT-->
</div><!--END LEFT-->
<div class="right"><!--START RIGHT-->
<br><br><br>
<a href="http://www.fda.gov"> <img src="images/FDA.gif" alt="FDA logo" title="FDA logo"/> </a><br/><br/>
<a href="http://www.aami.org"> <img src="images/AAMI.gif" alt="AAMI logo" title="AAMI logo"/> </a><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/>
<a href="http://www.massmedic.com"> <img src="images/massmedic.gif" alt="MassMedic logo", title="MassMedic logo"/> </a> <br/><br/>
</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>