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	<title>Critical Systems and Networks</title>
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	<link>http://www.critsys.com</link>
	<description>IT Management Solutions</description>
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		<title>Health/Wellness and Games</title>
		<link>http://www.critsys.com/index.php/blog/healthwellness-and-games/</link>
		<comments>http://www.critsys.com/index.php/blog/healthwellness-and-games/#comments</comments>
		<pubDate>Wed, 01 Jun 2011 14:52:41 +0000</pubDate>
		<dc:creator>pete</dc:creator>
				<category><![CDATA[Blog]]></category>

		<guid isPermaLink="false">http://www.critsys.com/?p=281</guid>
		<description><![CDATA[Had a friend forward me this article about Aetna using Mindbloom to increase health and wellness. Aetna encourages health through online gaming Reminds me of healthprize.com, and Kevin Volpps work at University of Pennsylvania. Behavioral economics and incentives is an &#8230; <a href="http://www.critsys.com/index.php/blog/healthwellness-and-games/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
			<content:encoded><![CDATA[<p>Had a friend forward me this <a href="http://www.healthcarepayernews.com/content/aetna-encourages-health-through-online-gaming">article</a> about Aetna using <a href="http://www.mindbloom.com/">Mindbloom</a> to increase health and wellness.</p>
<p><a href="http://www.healthcarepayernews.com/content/aetna-encourages-health-through-online-gaming">Aetna encourages health through online gaming</a></p>
<p>Reminds me of <a href="http://www.healthprize.com">healthprize.com</a>, and <a href="http://hcmg.wharton.upenn.edu/people/faculty.cfm?id=1527">Kevin Volpps</a> work at University of Pennsylvania.  Behavioral economics and incentives is an amazing area of focus to apply to health and wellness.  It reminds me of the books <a href="http://www.amazon.com/Predictably-Irrational-Hidden-Forces-Decisions/dp/0061854549">Predictably Irrational</a> and <a href="http://www.amazon.com/Freakonomics-Revised-Expanded-Economist-Everything/dp/0061234001/ref=sr_1_1?ie=UTF8&#038;s=books&#038;qid=1306939912&#038;sr=1-1">Freakenomoics</a>.  It is interesting to ask, &#8220;why do we behave the way we do; and how can technology help us change and grow&#8221;.</p>
<p>Pete Gordon</p>
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		<title>Microchip 32-bit and Arduino</title>
		<link>http://www.critsys.com/index.php/blog/microchip-32-bit-and-arduino/</link>
		<comments>http://www.critsys.com/index.php/blog/microchip-32-bit-and-arduino/#comments</comments>
		<pubDate>Sat, 28 May 2011 12:36:53 +0000</pubDate>
		<dc:creator>pete</dc:creator>
				<category><![CDATA[Blog]]></category>

		<guid isPermaLink="false">http://www.critsys.com/?p=272</guid>
		<description><![CDATA[Arduino does seem to be taking over the DIY and &#8220;Open source&#8221; world of embedded systems. Microchip has entered the frey with full force, and 32-bit. For more information than you probably want, then again you are reading this far; &#8230; <a href="http://www.critsys.com/index.php/blog/microchip-32-bit-and-arduino/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
			<content:encoded><![CDATA[<p><a href="http://en.wikipedia.org/wiki/Arduino">Arduino</a> does seem to be taking over the DIY and &#8220;Open source&#8221; world of embedded systems.  Microchip has entered the frey with full force, and 32-bit.  For more information than you probably want, then again you are reading this far; <a href="http://dangerousprototypes.com/forum/viewtopic.php?f=2&#038;t=2353">this discussion forum</a> goes into a lot of questions about Microchip, Arduino, Open Source and licensing at <a href="http://dangerousprototypes.com/forum/viewtopic.php?f=2&#038;t=2353">dangerousprototypes.com Microchip Arduino Discussion</a></p>
<p><iframe width="560" height="349" src="http://www.youtube.com/embed/ki1EVbxQo08" frameborder="0" allowfullscreen></iframe></p>
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		<title></title>
		<link>http://www.critsys.com/index.php/uncategorized/work/</link>
		<comments>http://www.critsys.com/index.php/uncategorized/work/#comments</comments>
		<pubDate>Fri, 13 May 2011 22:31:28 +0000</pubDate>
		<dc:creator>pete</dc:creator>
				<category><![CDATA[Uncategorized]]></category>

		<guid isPermaLink="false">http://www.critsys.com/?p=266</guid>
		<description><![CDATA[You made it this far! You are the type of person we want to work with! Do you want to work with a great team. Stay away from the corporate environment and work with people that trust you. We are &#8230; <a href="http://www.critsys.com/index.php/uncategorized/work/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
			<content:encoded><![CDATA[<p>You made it this far!  You are the type of person we want to work with!</p>
<p>Do you want to work with a great team.  Stay away from the corporate environment and work with people that trust you.  We are the place.  (www.critsys.com)</p>
<p>This is for an entry level position.</p>
<p>You need C programming experience to start.  We don&#8217;t care if it is 5 minutes or 5 years.  But, you need to know the foundation of software.  And, then build from there, into Object Oriented Development, C#, Java, PHP, Python, Javascript, Ruby (if you must) and all things Internet.</p>
<p>Next, you will need a passion for the Internet.  That means HTML/CSS/Javascript/JSON/JQuery/PDF; everything Internet related!  And, be willing to learn fast and put all of yourself into leveraging the Internet to build amazing software.</p>
<p>Lastly, communication skills are a must.  I know it is hard to be great with computers and programming and still be willing to work with people.  But, we are a tight knit group that rely on each other&#8211;so you must be excited about being part of our community&#8211;and we are excited to have you.</p>
<p>Some desire to get into embedded systems and programming would be good also.  (Microchip PIC, Arduino)</p>
<p>Drop us an email with your resume and let&#8217;s grab coffee and talk.  <a href="mailto:info@critsys.com?subject=BinaryHexMasterWork">info@critsys.com</a>  Add BinaryHexMaster to the Subject for us.</p>
<p>Thanks!<br />
Pete Gordon<br />
Director of Technology</p>
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		<title>Blue Button data format</title>
		<link>http://www.critsys.com/index.php/blog/blue-button-data-format/</link>
		<comments>http://www.critsys.com/index.php/blog/blue-button-data-format/#comments</comments>
		<pubDate>Mon, 09 May 2011 13:40:09 +0000</pubDate>
		<dc:creator>pete</dc:creator>
				<category><![CDATA[Blog]]></category>

		<guid isPermaLink="false">http://www.critsys.com/?p=258</guid>
		<description><![CDATA[Todd Park defends Blue Button using plain text format, without XML or more complicated CCD/CCR structure. I tend to agree with him. Although JSON is a good format as Facebook Graph and Google Map API has proven. http://www.meaningfulhitnews.com/2011/05/01/park-defends-plain-text-format-of-blue-button/ I am &#8230; <a href="http://www.critsys.com/index.php/blog/blue-button-data-format/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
			<content:encoded><![CDATA[<p>Todd Park defends Blue Button using plain text format, without XML or more complicated CCD/CCR structure.  I tend to agree with him.  Although JSON is a good format as Facebook Graph and Google Map API has proven.</p>
<p><a href="http://www.meaningfulhitnews.com/2011/05/01/park-defends-plain-text-format-of-blue-button/">http://www.meaningfulhitnews.com/2011/05/01/park-defends-plain-text-format-of-blue-button/</a></p>
<p>I am more concerned about the information reported than the format it is available in.  I have seen a medicare recepient data that doesn&#8217;t seem to correlate with the medicare claims you see through the Medicare Secondary Payer (MSP).  This has me concerned about the quality of the data, but now, how to get to the bottom of it.</p>
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		<item>
		<title>Meaningful Yoose Rap</title>
		<link>http://www.critsys.com/index.php/blog/meaningful-use-rap/</link>
		<comments>http://www.critsys.com/index.php/blog/meaningful-use-rap/#comments</comments>
		<pubDate>Wed, 13 Apr 2011 11:27:05 +0000</pubDate>
		<dc:creator>pete</dc:creator>
				<category><![CDATA[Blog]]></category>

		<guid isPermaLink="false">http://www.critsys.com/?p=248</guid>
		<description><![CDATA[Watch this Rap on Meaningful Use. One of the best ways to learn what the government is doing this year for physicians with the HITECH ACT. The Meaningful Yoose Rap from Ross Martin on Vimeo.]]></description>
			<content:encoded><![CDATA[<p>Watch this <a href="http://informatimusicology.blogspot.com/2011/03/meaningful-yoose-rap-music-video-world.html">Rap on Meaningful Use</a>.  One of the best ways to learn what the government is doing this year for physicians with the HITECH ACT.</p>
<p><iframe src="http://player.vimeo.com/video/20923483" width="400" height="225" frameborder="0"></iframe>
<p><a href="http://vimeo.com/20923483">The Meaningful Yoose Rap</a> from <a href="http://vimeo.com/user6272566">Ross Martin</a> on <a href="http://vimeo.com">Vimeo</a>.</p>
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		<title>Client Portfolio</title>
		<link>http://www.critsys.com/index.php/uncategorized/client-portfolio/</link>
		<comments>http://www.critsys.com/index.php/uncategorized/client-portfolio/#comments</comments>
		<pubDate>Sat, 19 Feb 2011 12:19:42 +0000</pubDate>
		<dc:creator>pete</dc:creator>
				<category><![CDATA[Uncategorized]]></category>

		<guid isPermaLink="false">http://www.critsys.com/?p=241</guid>
		<description><![CDATA[Here is a list of client companies that we have partnered with and have paid us for our expertise in HealthCare, the Internet, and Technology.  We would love to add your company name to this list. Contact us to discuss &#8230; <a href="http://www.critsys.com/index.php/uncategorized/client-portfolio/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
			<content:encoded><![CDATA[<p>Here is a list of client companies that we have partnered with and have paid us for our expertise in HealthCare, the Internet, and Technology.  We would love to add your company name to this list.</p>
<p>Contact us to discuss how we can partner together.</p>
<address>phone.  888-CRITSYS</address>
<address>email.  <a href="mailto:info@critsys.com">info@critsys.com</a></address>
<p>OHSS<br />
SleepCare, Inc.<br />
Self Employed Nurse Practitioners<br />
Lyntek Medical<br />
Dayton Lung<br />
Signature Dermatology<br />
Bexley Physical Therapy<br />
Practice Fusion<br />
Patient Safety</p>
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		<title>Combine Managed IT Services with Practice Fusion Free Web-based EHR</title>
		<link>http://www.critsys.com/index.php/blog/combine-managed-it-services-with-practice-fusion-free-web-based-ehr/</link>
		<comments>http://www.critsys.com/index.php/blog/combine-managed-it-services-with-practice-fusion-free-web-based-ehr/#comments</comments>
		<pubDate>Tue, 01 Feb 2011 15:44:50 +0000</pubDate>
		<dc:creator>pete</dc:creator>
				<category><![CDATA[Blog]]></category>

		<guid isPermaLink="false">http://www.critsys.com/?p=226</guid>
		<description><![CDATA[Here is a video slide show explaining the EHR Marketplace, and why combining Managed IT Services with PracticeFusion free web-based EHR makes sense for small and mid-sized health care providers.]]></description>
			<content:encoded><![CDATA[<p>Here is a video slide show explaining the EHR Marketplace, and why combining Managed IT Services with PracticeFusion free web-based EHR makes sense for small and mid-sized health care providers.</p>
<p><iframe title="YouTube video player" type="text/html" width="640" height="390" src="http://www.youtube.com/embed/mt0ZpU0Uvm0" frameborder="0" allowFullScreen></iframe></p>
]]></content:encoded>
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		<title>Health 2.0 Practice Fusion Challenge</title>
		<link>http://www.critsys.com/index.php/blog/health-2-0-practice-fusion-challenge/</link>
		<comments>http://www.critsys.com/index.php/blog/health-2-0-practice-fusion-challenge/#comments</comments>
		<pubDate>Tue, 01 Feb 2011 15:41:24 +0000</pubDate>
		<dc:creator>pete</dc:creator>
				<category><![CDATA[Blog]]></category>

		<guid isPermaLink="false">http://www.critsys.com/?p=223</guid>
		<description><![CDATA[Here was our presentation at the Health 2.0 conference showing a hacked Escali scale and Practice Fusion and MS HealthVault integration. http://health2challenge.org/blog/real-time-patient-driven-data-challenge/ If you are interested in the source code and more about the project, check out the code on &#8230; <a href="http://www.critsys.com/index.php/blog/health-2-0-practice-fusion-challenge/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
			<content:encoded><![CDATA[<p><embed src='http://www.health2con.com/mediaplayer/player-licensed-viral.swf' height='327' width='436' allowscriptaccess='always' allowfullscreen='true' flashvars="&#038;bandwidth=2377&#038;controlbar.margin=0&#038;controlbar.size=32&#038;dock=false&#038;file=http%3A%2F%2Fhealth2con.com.s3.amazonaws.com%2FSF10%2Fshowcase_winners%2Freal_time_data.f4v&#038;icons=false&#038;image=http%3A%2F%2Fhealth2challenge.org%2Fwp-content%2Fuploads%2F2010%2F11%2Fpatientdriven1.png&#038;level=0&#038;logo=%2Flogos%2Fh20tvforplayer.png&#038;plugins=viral-2d&#038;skin=http%3A%2F%2Fwww.health2con.com%2Fmediaplayer%2Fskins%2Fsnel%2Fsnel.swf"/></p>
<p>Here was our presentation at the Health 2.0 conference showing a hacked Escali scale and Practice Fusion and MS HealthVault integration.</p>
<p><a href="http://health2challenge.org/blog/real-time-patient-driven-data-challenge/">http://health2challenge.org/blog/real-time-patient-driven-data-challenge/</a></p>
<p>If you are interested in the source code and more about the project, check out the code on codeplex:</p>
<p>http://pfsync.codeplex.com</p>
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		<title>Could Time and Money Run Out on Heathcare Providers?</title>
		<link>http://www.critsys.com/index.php/blog/could-time-and-money-run-out-on-heathcare-providers/</link>
		<comments>http://www.critsys.com/index.php/blog/could-time-and-money-run-out-on-heathcare-providers/#comments</comments>
		<pubDate>Thu, 09 Dec 2010 17:06:51 +0000</pubDate>
		<dc:creator>mark</dc:creator>
				<category><![CDATA[Blog]]></category>

		<guid isPermaLink="false">http://www.critsys.com/?p=219</guid>
		<description><![CDATA[Like many of us do in everyday life, we procrastinate. We put off the inevitable and try to delay the final outcome of a situation by not dealing with it and confronting it face to face. Why do we think &#8230; <a href="http://www.critsys.com/index.php/blog/could-time-and-money-run-out-on-heathcare-providers/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
			<content:encoded><![CDATA[<p>Like many of us do in everyday life, we procrastinate. We put off the inevitable and try to delay the final outcome of a situation by not dealing with it and confronting it face to face. Why do we think that way? After some considerable thought on this issue, I realized that as people we don&#8217;t like change and we are fearful that the change we initiate may make our life harder.</p>
<p>This is true in my life after recently changing our cable provider for a less expensive service, I quickly realized that the new service did not provide me with the same menu function. This initially frustrated me and made my surfing ability less efficient due to the new buttons and functions I had to learn. After some time and learning, I realized the new service was indeed much more efficient and offered me more detail when it came to selecting and marking my channels for recording. In the long run this change for me has been more beneficial, due to the function-ability of the service while saving me considerable money. While the short term was painful, the change had to take place and now I am glad that I did it.</p>
<p>In my current position as the Director fo Business Development for Critical Systems I run into health care providers everyday that have the same mindset as I did. There pain could be the hours of required training the entire staff on a new EHR system, the imputing of paper files, and the fear of losing patients due to the perceived short term inefficiency of the office staff while learning the system. While these thoughts are all understandable, the consequences of not changing could become a serious issue to many practices if they don&#8217;t consider to implement an EHR shortly.</p>
<p>According to a new survey from Physicians&#8217; Reciprocal Insurers, Healthcare IT News reports. Under the 2009 economic stimulus package, health care providers who demonstrate meaningful use of EHRs will be eligible for incentive payments through Medicare and Medicaid. However, beginning in January 2015, health care providers who are not meaningfully using EHRs will face penalties equal to a 1% reduction in annual Medicare payments per year up to 5%.</p>
<p>The survey of more than 500 physicians found that while 85% of physicians were aware of the incentive payments, more than 35% of doctors said they were unaware of the penalties. However, of those who were unaware of the penalties, more than 65% said the penalties would not drive them to adopt an EHR system.</p>
<p>Among physicians who plan to adopt EHRs, 85% said they are &#8220;very&#8221; or &#8220;somewhat&#8221; concerned about the cost, and 79% said they are &#8220;very&#8221; or &#8220;somewhat&#8221; concerned about staff training. Despite these concerns, more than 58% of the respondents said that EHRs will have a positive or very positive effect on patient care and quality (Merrill, Healthcare IT News, 9/23). (iHealthbeat; Septemebr 24, 2010)</p>
<p>As you can see the negative effect in not implementing can cause a practice to loose considerable money if they are not prepared. Another factor that can cause providers problems is the amount of stimulus that may not be available if the provider waits too long. Of the $36 billion stimulus funding for EHR, $33 billion is expected to go to providers with early adopters receiving the biggest payments. So waiting in this case may find you in a real tough position.</p>
<p>This opportunity is timed-based. For every day the implementation is delayed, the practices lose a portion of the incentive. Funding decreases over time and it will go away after 2015. Every day a practice waits, is a missed opportunity to take advantage of financial incentives.</p>
<p>The time is now, so why procrastinate!</p>
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		<title>FDA and the Internet</title>
		<link>http://www.critsys.com/index.php/blog/fda-and-the-intenet/</link>
		<comments>http://www.critsys.com/index.php/blog/fda-and-the-intenet/#comments</comments>
		<pubDate>Wed, 24 Nov 2010 22:54:46 +0000</pubDate>
		<dc:creator>pete</dc:creator>
				<category><![CDATA[Blog]]></category>

		<guid isPermaLink="false">http://www.critsys.com/?p=205</guid>
		<description><![CDATA[The FDA 510k process is known for its difficulty to manage in the project lifecycle, particularly for start-up companies where your investment lifeline is likely short and discreet.  It makes managing Internet Software projects with an FDA 510k requirement all &#8230; <a href="http://www.critsys.com/index.php/blog/fda-and-the-intenet/">Continue reading <span class="meta-nav">&#8594;</span></a>]]></description>
			<content:encoded><![CDATA[<p>The FDA 510k process is known for its difficulty to manage in the project lifecycle, particularly for start-up companies where your investment lifeline is likely short and discreet.  It makes managing Internet Software projects with an FDA 510k requirement all the more difficult.  The classical &#8220;<a href="http://en.wikipedia.org/wiki/Waterfall_model">waterfall</a>&#8221; documentation approach to software development was provided by the FDA as guidance to those developing software for the FDA in 2005, <em><a title="FDA Software" href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm">Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices</a> (see Table 3).<span id="more-205"></span></em></p>
<p>If I have kept your interest this long, then now it is time to talk about the real concern.  While the documentation requirements are interesting, the real concern I believe is not HOW do I get FDA 510k approved and the documents that I need to submit; but rather the WHAT do I get FDA 510k approved.  I spoke with an HHS representative a several weeks ago in California and discussed a bathroom weight scale that sends data over the Internet to twitter and Practice Fusion EHR and HealthVault PHR (<a href="http://www.practicefusion.com/pages/pr/winner-of-healthcare-api-challenge.html">see more here</a>).  I asked, &#8220;If a scale communicates weight up to the Internet, goes into a EHR, is used by the physician or nurse to contact the patient because they may be at risk of hospitalization for CHF, does the scale and the Internet application need FDA 510k approval?&#8221;.  It gets even more interesting, if the Internet application uses a rule of thumb, say maybe, weight gain of 2-<em>3 pounds</em> or more per day over a 2-day period or 5 <em>pounds </em>in 1 week, and then notifies the HealthCare provider based on this rule.  She didn&#8217;t have an answer, and said it was an interesting question.  Bathroom scales tend to be FDA approved when they do Body Composition and are used directly by a HealthCare provider organization.  HealthCare providers that I have talked with tend to trust that the supplying company, the DME/HME, have already confirmed that the scale they are providing is FDA approved.</p>
<p>All of this said, it seems, the most interesting question is not HOW does one get FDA 510k approval, especially for start-up Internet companies; but WHAT does one get FDA 510k approved in the world of the Internet where connections of valuable Health information are made so easily.  I don&#8217;t what to go down the path of fear and say everything needs to be FDA approved, but at the same time I would like to encourage the FDA to make the process as streamlined as possible and allow innovative companies to easily dialog about these types of questions with the FDA so they can continue to produce the breakthrough medical devices and software, and yes, even FDA 510k Internet Software that keeps us on the leading edge of HealthCare Technology innovations.</p>
<p><strong>Table 3. Documentation Based on Level of Concern</strong></p>
<table id="rrtable5" border="1" cellspacing="2" cellpadding="2">
<tbody>
<tr id="rrtr17">
<th width="162" valign="top"><strong>SOFTWARE DOCUMENTATION</strong></th>
<th width="117" valign="top"><strong>MINOR CONCERN</strong></th>
<th width="119" valign="top"><strong>MODERATE CONCERN</strong></th>
<th width="134" valign="top"><strong>MAJOR CONCERN</strong></th>
</tr>
<tr id="rrtr18">
<td id="rrtd18" width="162" valign="top"><a id="rrtaa59" href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm#_Level_of_Concern_Statement">Level of Concern</a></td>
<td id="rrtd19" colspan="3" width="370" valign="top">A statement indicating the Level of Concern and a description of the rationale for that level.</td>
</tr>
<tr id="rrtr19">
<td id="rrtd20" width="162" valign="top"><a id="rrtaa60" href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm#_Software_Description">Software Description</a></td>
<td id="rrtd21" colspan="3" width="370" valign="top">A summary overview of the features and software operating environment.</td>
</tr>
<tr id="rrtr20">
<td id="rrtd22" width="162" valign="top"><a id="rrtaa61" href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm#_Device_Hazard_Analysis">Device Hazard Analysis</a></td>
<td id="rrtd23" colspan="3" width="370" valign="top">Tabular description of identified hardware and software hazards, including severity assessment and mitigations.</td>
</tr>
<tr id="rrtr21">
<td id="rrtd24" width="162" valign="top"><a id="rrtaa62" href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm#_Software_Requirements_Specification">Software Requirements Specification</a> (SRS)</td>
<td id="rrtd25" width="117" valign="top">Summary of functional requirements from SRS.</td>
<td id="rrtd26" colspan="2" width="253" valign="top">The complete SRS document.</td>
</tr>
<tr id="rrtr22">
<td id="rrtd27" width="162" valign="top"><a id="rrtaa63" href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm#_Architecture_Design_Chart">Architecture Design Chart</a></td>
<td id="rrtd28" width="117" valign="top">No documentation is necessary in the submission.</td>
<td id="rrtd29" colspan="2" width="253" valign="top">Detailed depiction of functional units and software modules. May include state diagrams as well as flow charts.</td>
</tr>
<tr id="rrtr23">
<td id="rrtd30" width="162" valign="top"><a id="rrtaa64" href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm#_Software_Design_Specification">Software Design Specification</a> (SDS)</td>
<td id="rrtd31" width="117" valign="top">No documentation is necessary in the submission.</td>
<td id="rrtd32" colspan="2" width="253" valign="top">Software design specification document.</td>
</tr>
<tr id="rrtr24">
<td id="rrtd33" width="162" valign="top"><a id="rrtaa65" href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm#_Traceability_Analysis">Traceability Analysis</a></td>
<td id="rrtd34" colspan="3" width="370" valign="top">Traceability among requirements, specifications, identified hazards and mitigations, and Verification and Validation testing.</td>
</tr>
<tr id="rrtr25">
<td id="rrtd35" width="162" valign="top"><a id="rrtaa66" href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm#_Software_Development_Environment_De">Software Development Environment Description</a></td>
<td id="rrtd36" width="117" valign="top">No documentation is necessary in the submission.</td>
<td id="rrtd37" width="119" valign="top">Summary of software life cycle development plan, including a summary of the configuration management and maintenance activities.</td>
<td id="rrtd38" width="134" valign="top">Summary of software life cycle development plan. Annotated list of control documents generated during development process. Include the configuration management and maintenance plan documents.</td>
</tr>
<tr id="rrtr26">
<td id="rrtd39" width="162" valign="top"><a id="rrtaa67" href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm#_Verification_and_Validation_Documen">Verification and Validation Documentation</a></td>
<td id="rrtd40" width="117" valign="top">Software functional test plan, pass / fail criteria, and results.</td>
<td id="rrtd41" width="119" valign="top">Description of V&amp;V activities at the unit, integration, and system level. System level test protocol, including pass/fail criteria, and tests results.</td>
<td id="rrtd42" width="134" valign="top">Description of V&amp;V activities at the unit, integration, and system level. Unit, integration and system level test protocols, including pass/fail criteria, test report, summary, and tests results.</td>
</tr>
<tr id="rrtr27">
<td id="rrtd43" width="162" valign="top"><a id="rrtaa68" href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm#_Unresolved_Anomalies_(Bugs)">Revision Level History</a></td>
<td id="rrtd44" colspan="3" width="370" valign="top">Revision history log, including release version number and date.</td>
</tr>
<tr id="rrtr28">
<td id="rrtd45" width="162" valign="top"><a id="rrtaa69" href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm#_Unresolved_Anomalies_(Bugs_or Defec">Unresolved Anomalies (Bugs or Defects)</a></td>
<td id="rrtd46" width="117" valign="top">No documentation is necessary in the submission.</td>
<td id="rrtd47" colspan="2" width="253" valign="top">List of remaining software anomalies, annotated with an explanation of the impact on safety or effectiveness, including operator usage and human factors.</td>
</tr>
</tbody>
</table>
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