Published on February 19, 2014
PAGE 1 agileMed 2014 codeBeamer Medical ALM for Medical Device Development PRESENTER: Rico Unger 2014 FEB 19 WWW.INTLAND.COM
2005-2013 Statistics 170 180 160 170 143 140 120 Software Recall 100 Number of software recall increased by 100% from 2010 to 2011 86 80 69 65 2006 80 72 2007 60 40 34 20 Number of increasing 1st class recall 0 2005 2008 2009 2010 2011 2012 2013 6 1st In 2014 3 new class recall already published 5 5 5 4 3 3 3 Average 80% are 2nd class recalls 2 1 1 1 1 0 0 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 WWW.INTLAND.COM PAGE 2 FDA Recall
PAGE 3 Key Issues Medical Device Producers face challenges Reducing recall due to “embedded” software products’ failures Mitigate risk properly Achieve compliance with standards IEC/ISO/FDA Balance effort/cost of quality assurance WWW.INTLAND.COM
IEC 62304 compliance support SOLUTION codeBeamer is a complex ALM solution supporting IEC 62304 standard based development with Agile and Waterfall (V-model) methods DemandRequiremenst Management SCCM Test and QA IT OperationDevops WWW.INTLAND.COM PAGE 4 Application Lifecycle Management
PAGE 5 Overview Medical Wiki Requirements Trackers Risk Management Release Management Document Management Test and QA WWW.INTLAND.COM
Web-based Available via Browsers, (supported databases are: MySQL, Oracle) PAGE 6 General Features Customizable Trackers, workflows, permission, dashboards User-friendly GUI Well-structured GUI, intuitive, easy to use RESTful API Integration to third party applications - IEC 62304 compliance list WWW.INTLAND.COM
PAGE 7 Medical WIKI Medical Domain Knowledge Base Covers all chapters of IEC 62304 Direct links to codeBeamer trackers, reports, workflow to provide evidence Main elements: • Software Development Plan • Traceability matrix • Risk Management • Reports and Dashboards WWW.INTLAND.COM
1 IEC 62304 chapters and links to codeBeamer support 2 Traceability matrix 3 QA Dashboards 4 Reports WWW.INTLAND.COM PAGE 8 Medical wiki
PAGE 9 Medical Trackers Configuration Items A Requirements Trackers B Releases, Test Cases, Test Runs Risk Tracker C Change Request Tracker WWW.INTLAND.COM
1 System, Software, Architecture 2 SOUP 3 Requirement Approval Workflow WWW.INTLAND.COM PAGE 10 Medical Trackers
Test Case 1 Requirement Test Case 2 Test Case....n Test Case definition based on Requirements TEST SETS PAGE 11 Test Management and QA Test Run 1 Test Run 2 Test Run..n Add test Cases to Test runs Verify all Requirements Release 1.1....n WWW.INTLAND.COM
PAGE 12 Risk Management Workflow Mitigation action documented New Submit Verified Reduction planned Transition set Mitigated Risk Tracker History WWW.INTLAND.COM
PAGE 13 Risk Assessment Assess Inherent Risk Severity and Likehood = IH Risk Define mitigation action Residual riskmitigated Severity and Likehood after mitigation = RR WWW.INTLAND.COM
Release Planning Kanban Board Release Verification Add requirements to release from backlog Task status with WIP limits All RMs are released and tested WWW.INTLAND.COM PAGE 14 Release Management
PAGE 15 Document Management Central Document Repsitory, Versioning, Permissions Process Templates QMS documentation Risk Management File WWW.INTLAND.COM
PAGE 16 Benefits What you can achieve by implementing medical ALM? + Easier standardization and audits - IEC 62304 - cost reduction, increase efficiency of audits + Significant time savings + Full traceability + Agile-Waterfall - Implementation effort can be reduced by 5-6 days - Reduce cycle times, test case coverage, status management - Both development methods are supported WWW.INTLAND.COM
PAGE 17 Intland Software Your German Partner Intland Software is an Application Lifecycle Management (ALM) solution provider. At Intland we are building software for great companies to make their systems better. Established 1993 25.000 + 90.000+ codeBeamer users worldwide OSS-Javaforge users North-America Silicon Valley Germany HQ, Stuttgart WWW.INTLAND.COM
PAGE 18 Customers WWW.INTLAND.COM
PAGE 19 Contact email@example.com Headquarters Stuttgart - Germany Gropiusplatz 10 Download medical ALM with codeBeamer 7.2.1 from: http://intland.com/download-center/ WWW.INTLAND.COM
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Learn more about codeBeamer Medical ALM, our customized template for IEC 62304 compliance which is required for medical device development at AgileMed 2014.
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E 1 WWW.INTLAND.COM PRESENTER: Rico Unger 2014 FEB 19 codeBeamer Medical ALM for Medical Device Development agileMed 2014