Acquisition Assessment and Remediation
Acquisition Assessment and Remediation
The RND Group recently partnered with a leading medical device company who filled a portfolio gap by purchasing a niche software company in Europe. Their acquisition of this company included a large laboratory management software package.
Software Technologies
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Microsoft Windows 2012 Server – Target OS
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JAMA – Requirement, Test Case & Test Execution
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Oracle 11.2 – Target Database
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LIS2-A2 / ASTM 1394 – Laboratory Communications
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Oracle Virtual Box – Test Environments
Capabilities Applied
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FDA Part 820, Part 11
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Requirements development and management
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ISO 13485, HIPAA, IEC 62304
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Software risk analysis and management
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Software life cycle processes
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Project management
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Software verification
