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1 codebeamer Medical ALM Solution is built for INTLAND Traceability matrix Medical wiki Risk management IEC compliance codebeamer

2 INTLAND codebeamer Medical ALM Solution is built for Medical Device development teams are faced with increased software complexity when developing high quality devices. It is essential to manage risk and meet standards for safety equipment to ensure patient safety. The medical industry is highly regulated with standards to define and maintain software quality and control risk. IEC codebeamer Medical ALM assists manufacturers to be compliant with IEC international regulation, the mandatory standard for manufacturers of medical devices. codebeamer Medical ALM provides the full functionality of a complex ALM solution. It includes requirements, development and test management customized to meet users needs. codebeamer ALM is built for Medical Device Development and for IEC Regulatory Compliance

3 codebeamer Medical ALM Solution is built for INTLAND Specific Medical Trackers Customers, Systems, Software and Architecture related trackers are defined to collect all requirements attached to the medical device. The integrated traceability matrix shows the dependences among requirements and risks. Risk Management Our specific medical risk tracker is developed with a risk management workflow and the support of classification of modules or components. Medical Wiki The Medical wiki fully supports the compliance with IEC as its content covers the standard requirements. The Medical wiki provides the users of codebeamer Medical Project with domain knowledge and it supports the application of rules across the whole development lifecycle. Medical Document Management with Templates The document management module is equipped with template documents and process descriptions based on the IEC standard requirements. Integrated Release and Test Management This feature ensures full traceability of the development process. The release and test management modules are customized to guarantee control and measurement on release delivery and product quality.

4 codebeamer function Chapter of IEC Trackers Configuration Items Medical Wiki Document Management SCM Repositories Reports Test Management 4 General requirements 4.1 Quality management system Defined in corporate documentation 4.2 Risk management l l 4.3 Software safety classification l l 5 Software development process 5.1 Software development planning l l Software development plan, updates, definition of standards methods and tools. Test and verification planning, risk management, documentation and configuration planning. 5.2 Software requirements analysis l l l l System-Software-requirements definition, risk control measures, risk evaluation and mitigation. 5.3 Software architectural design l l l Architecture requirements, SOUP definition, hardware requirements, risk control measures and verification. 5.4 Software detailed design l l l Design for software units, interface design, software unit implementation, verification and acceptance. 5.5 Software unit implementation and verification l l 5.6 Software integration and integration testing l l Software integration and integration testing, software units integration, test inteagration, verification, regression test, problem resolution process. Design for software units, interface design, software unit implementation, verification and acceptance. 5.7 Software systems testing l l 5.8 Software release l l l l Software release verification, evaluate residual anomalies, documentation task completation report, archive and repeatability of software releases. 6 Software maintenance process 6.1 Establish software maintenance plan l l 6.2 Problem and modification analysis l Feedback documentation, evaluation and monitoring, safety problem reports, change request analysis, CRQ approval, communication to users. 6.3 Modification implementation l l Use established process to implement modification, re-release modified software system. 7 Software risk management process 7.1 Analysis of software contributing to hazardous situations l l Identify software items that could contribute to a hazardous situation and potential causes of contribution to a hazardous situation, evaluate published SOUP anomaly lists and prepare documentation. 7.2 Risk control measures l l Define risk control measures, and implement risk control measures in software development. 7.3 Verification of risk control measures l l Identify software items that could contribute to a hazardous situation and potential causes of contribution to a hazardous situation 7.4 Risk management of software changes l Analyse changes to medical device software with respect to safety, analyse impact of software changes on existing risk control, perform risk management activities based on analyses. 8 Software configuration management process 8.1 Configuration identification l l Establish means to identify configuration items, identify SOUP, identify system configuration documentation. 8.2 Change control l l Approve change requests (CRQ), implement and verify change, provide means for traceability of changes. 8.3 Configuration status accounting l l 9 Software problem resolution process 9.1 Prepare problem reports l l 9.2 Investigate the problem l l 9.3 Advise relevant parties l l 9.4 Use change control process l l 9.5 Maintain records l l 9.6 Analyse problems for trends l l 9.7 Verify software problem resolution l l 9.8 Test documentation contents l l

5 codebeamer Medical ALM Solution is built for INTLAND Main Benefits of codebeamer Medical ALM codebeamer ALM is designed for the medical industry and compliance with IEC Manufacturers of medical devices can benefit from significant cost savings, in terms of both time and effort reducing the implementation time by 90%. The medical template is flexible and can be customized to work with internal processes and practices. Access to domain knowledge codebeamer Medical ALM is developed with domain experts and therefore contains in-depth domain knowledge based on the IEC standard and available practices. codebeamer Medical ALM solution includes integrated document management, wiki and a wide range of collaboration features that saves time and effort of medical device development T For further details please visit our website: /solutions/by-industry/medical-devices/ According to an FDA analysis of medical device recalls ( ), 7.7% were attributable to software failures. 79% of those were caused by software defects introduced after software upgrades.

6 INTLAND codebeamer Medical ALM Solution is built for codebeamer ALM at a Glance Demand Management l Project Management (PPM) l Requirements Management l Change and Configuration Management l Test and QA Management l Document Management and Versioning l Workflow Management l Web-based Collaboration l

7 Intland Software is a dynamically growing player in the Application Lifecycle Management market. The company s mission is to increase the quality of the customers software development processes. codebeamer, the Jolt award-winning development suite from Intland Software assists companies in managing their requirements and specifications, recently enhanced by features for Demand Management. Our medical references: Free download: /products/downloads

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