The RND Group Assists a Leading Medical Diagnostics Company in Acquisition Assessment and Remediation

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The RND Group recently completed a project with an industry-leading medical diagnostics company to assess and remediate a software package for use in FDA-regulated environments.   The company filled a portfolio gap through an acquisition of a niche software company in Europe.   The acquisition included a large laboratory management software package.

The RND Group performed a gap analysis on the product’s software development documentation to determine compliance with FDA requirements.   Using the results of the analysis as guidance, over 80 user needs and 1000 product requirements were added to the Design History File.  A risk assessment was also performed as part of the analysis and used to further define the remediation work.

A large portion of the remediation was the creation of a verification package for the new requirements, which was created by The RND Group. The verification package included a verification testing plan, verification test cases and execution of the verification artifacts.    The Risk Assessment was leveraged to assure the testing methods were effective as well as efficient.

The RND Group leveraged the client’s quality management system allowing for a seamless handover at the end of the project.    All user needs, requirements and verification test cases were written and managed in JAMA allowing for efficient collaboration with a distributed team (Chicago, Indianapolis, Dallas and Milan Italy).

The project demonstrated that an existing product can be brought into line with the FDA documentation requirements.    The RND Group’s extensive knowledge of medical device standards allowed us to assess the gaps, develop a plan to address the deficiencies and execute the plan to bring the product into compliance.

The RND Group specializes in the definition and delivery of FDA-regulated software for medical devices. We are a team of people who excel in our craft, blending skill with passion to build software to meet exacting standards. Each project is developed with an unmatched attention to
detail, a tireless passion for perfection and a drive to architect a solid foundation for the future.

With over 20 years of experience in regulated software engineering, we’ve built a heritage and reputation for building specialized software with precision and care. The RND Group can point with pride to products that have been successfully introduced into the medical device marketplace.

Capabilities Applied

  • FDA Part 820, Part 11
  • ISO 13485, HIPAA, IEC 62304
  • Software life cycle processes
  • Requirements development and management
  • Software risk analysis and management
  • Project management
  • Software verification

Software

Technologies Used

  • Microsoft Windows 2012 Server – Target OS
  • Oracle 11.2 – Target Database
  • Oracle Virtual Box - Test Environments
  • JAMA – Requirement, Test Case & Test Execution
  • LIS2-A2 / ASTM 1394 - Laboratory Communications