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<h1>Training for the Medical Device Industry</h1>
Medical device software needs to be developed in compliance with FDA regulations including:
<ul style="list-style-type: circle;"> <ul class="indent">
<span class="bold">
<li>FDA Quality Management System Regulation (QMSR)</li>
<li>FDA Guidance Documents </li>
<li>EU Regulations: MDR and IVDR</li>
<li>Standards: ISO-13485, ISO-14971, IEC-62304, IEC-62366-1,
<li>Standards: ANSI AAMI SW96 and AAMI TIR 57</li>
</ul></span>
<br/>
The training courses I offer can help your staff understand and interpret the regulations, FDA Guidance documents,
and international standards from a <span class="bold">software perspective</span> and in a manner that is consistent with
regulatory expectations and industry best practice. My extensive software development experience and first-hand knowledge of
regulatory expectations can help your staff learn what is and is not required as well as how to be compliant in the
most cost-effective manner.<p>
<br/><br/>
<h1>Public Training Courses</h1>
Public training courses are usually full day or two day courses on a variety of topics. In a public course,
people from different companies and backgrounds participate in discussions and interactive exercises. Not only do you
benefit from the training but also from interacting with people in other companies often facing the same challenges you are.
<br/><br/>
<img src="images/arrow.gif" alt="arrow" title="arrow"/><a href="training_public.html"> Click here to view a current schedule of public training courses.</a><br/><br/>
<h1>On-site Training Courses</h1>
On-site training courses are presented to project teams and groups at your facility. This affords your staff the opportunity
for everyone to hear the same message and participate in group discussions and interactive exercises. I often tailor
on-site courses based on the client’s specific training needs. Tailored, on-site training provides one of the most
cost-effective ways to train teams and improve skills.<br/>
<br/>Contact me via <span class="bold">E-mail:</span> <a href="mailto:[email protected]">
Steven Rakitin </a> for more details on training options. <br/><br><br>
<!--
Click on the course for an overview and syllabus:<br/>
<ul class="indent">
<li><a href="training_medical_software_dev.html">Software Development for Medical Device Manufacturers</a></li>
<li><a href="training_medical_verification.html">Software Verification & Validation for Medical
Device Manufacturers</a> </li>
<li><a href="training_medical_risk_management.html">Risk Management for Medical Device Manufacturers</a></li>
</ul><br/>
<h1>Live Online Training Courses</h1>
Live online training courses are like public courses but they are presented using web meeting software so many people from different locations can participate with having to travel.
Working with the <a href="http://ieeeboston.org"> IEEE Boston Section,</a> I have created a live online course based on the syllabus I developed for my two-day course titled <a href="training_medical_software_dev.html">Software Development for Medical Device Manufacturers.</a><br/><br/>
<img src="images/arrow.gif" alt="arrow" title="arrow"/><a href= "http://ieeeboston.org/event/live-course-software-development-for-medical-device-manufacturers/?instance_id=2862"> Click here to get more information or to register for my live online course.</a><br/><br/>
<h1>Video Training Courses</h1>
Video courses allow individuals to benefit from training by viewing a course at their own pace and at a time of their
choosing. Working with the <a href="http://ieeeboston.org"> IEEE Boston Section,</a> I have created a video course based on the syllabus I developed for my two-day course titled <a href="training_medical_software_dev.html">Software Development for Medical Device Manufacturers.</a><br/><br/>
<img src="images/arrow.gif" alt="arrow" title="arrow"/><a href= "http://ieeeboston.org/software-development-medical-device-manufacturers-line-course/"> Click here to get more information or to register for my video course.</a><br/><br/>
<h1>Brown bag seminars </h1>
Brown bag seminars are a collection of short, focused, informal seminars aimed at helping organizations improve
predictability, productivity, quality, and time-to-market. By presenting focused topics in a short (about an hour)
informal setting, your staff can learn new methods and techniques that can help them in their work without affecting
time-critical project schedules. <br/><br/>
Brown bag seminars can also be used as a forum for discussing compliance issues and for sharing ideas and experiences.
Brown bag seminars can be presented in person in the New England area or using browser-based remote meeting tools.<br/><br/>
<span class="bold">Brown Bag Seminar Topics </span><br/>
<ul class="indent">
<li>Overview of Software Development for Medical Devices</li>
<li>Overview of Risk Management for Medical Devices </li>
<li>Documenting Complaints and Root Cause Analysis </li>
<li>Improving the Effectiveness of Medical Device Software Validation</li>
<li>Overview of 21 CFR Part 11—Electronic Records and Signatures </li>
</ul><br/>
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