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Verification, Validation, IEC 62304, ISO 13485, ISO 14971, IEC 62366-1, ANSI/AAMI SW96, SW96, 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, Safety Risk Management, Security Risk Management, 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"/>
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<img src="images/home.gif" alt="Providing a full range of consulting, training, and auditing services for the Medical Device, BioTech and Pharma Industries." title="Providing a full range of consulting, training, and auditing services for the Medical Device, BioTech and Pharma Industries."/>
<br/>
<h1 align = left>Training services including:</h1>
<br>
<ul class="indent_home">
<ul style="list-style-type: disc;">
<li><b>Prepare for ISO-13485 QMSR Compliance</b></li>
<li>Software Development for Medical Devices </li>
<li>Safety and Security Risk Management </li>
</ul><br>
<h1 align=left>Consulting services to help your organization:</h1>
<br>
<ul class="indent_home">
<ul style="list-style-type: disc;">
<li>Develop a compliant and cost-effective Quality Management System </li>
<li>Create SOPs based on Regulations, Guidance Documents and Standards </li>
<li>Comply with IEC-62304 Software Development Lifecycle</li>
<li>Comply with ISO-14971 Safety Risk Management</li>
<li>Comply with ANSI/AAMI SW96 Security Risk Management</li>
<li>Comply with ISO-13485 Quality Management Systems</li>
<li>Comply with IEC-62366-1 Usability Engineering</li>
</ul><br>
<h1 align = left>Auditing services to help:</h1>
<br>
<ul class="indent">
<li>Prepare for FDA and Notified Body audits</li>
<li>Assess compliance with internal SOPs </li>
<li>Assess compliance with Regulations, Guidance Documents and Standards</li>
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