Invent

bioMérieux, Inc.


bioMérieux, Inc. specializes in the in-vitro diagnostics sector. They design, develop, produce, and market diagnostic systems for medical and industrial applications.

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Project: Provide documentation and software verification & validation for viral detection system.

Challenge:

  • Document and perform verification testing of instrument software used for a viral meningitis early detection system.
  • Ensure that development complies with FDA medical device regulations to 510(k) medical device submission.

Results Delivered:

  • State of development assessed and recommendations presented to meet program goals.
  • Development streamlined by utilizing proven design control procedures, version control, and defect management systems.
  • Final project documentation and development met FDA medical device regulations.

Code Refinery brings a complete compliance solution prospectively and retrospectively to a client. This includes requirements, specification, verification, and validation along with all of the prerequisite design control documentation and traceability. Their experience helps to efficiently provide the appropriate level of evidence to document that ‘we say what we do and do what we say.’ Code Refinery has established themselves as a solid development partner.”

— Director, Instrument Research and Development, bioMérieux, Inc.

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Project: Create necessary 510 (k) documentation for FDA clearance of an in-vitro diagnostic instrument.

Challenge:

  • Develop FDA 510(k) documentation for software and instrumentation sections of a medical device submission for the NucliSENS EasyQ® Enterovirus instrument

Results Delivered:

  • Performed gap analysis between existing documentation against and requirements for a FDA 510(k) medical device submission.
  • Managed project teams in the US and Europe to coordinate efforts around device 510 (k) for the NucliSENS EasyQ® Enterovirus instrument.
  • Helped achieve FDA clearance for the NucliSENS EasyQ® Enterovirus instrument.

We got an official FDA review letter just before Christmas. That letter did not contain a single question on Software and Instrumentation. We asked the FDA reviewer if there would be any more questions regarding the submission. The reviewer said that this was the complete review. So, Code Refinery, many kudos to you!”

—Global Project Management, bioMérieux, Inc.

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Project: Perform software verification and validation testing for clinical instrument information management system.

Challenge:

  • Develop and execute software verification and validation protocols for the OBSERVA software.
  • Coordinate and manage verification and validation program and staffing.
  • Execute software V&V with multiple clinical instrument and software configurations.
Results Delivered:
  • Quickly assembled on-site team to create and execute verification test cases.
  • Performed on-going traceability and risk analysis.
  • Assumed overall project management responsibility for V&V effort and added additional validation staff.
  • Met timeline and allowed client to begin the software release process.

I can only say good things about Code Refinery–the people and the quality of work.  Code Refinery has been a critical ally for quite a while now in getting the OBSERVA 3 product to market.  I am happy to say, we hope to reach this goal by the end of January 2008.  All the members of the Code Refinery Team we have dealt with are consummate professionals with an admirable work ethic.  We really appreciate the willingness and ability of the Code Refinery Team to help us in our time of need.  I would work with Code Refinery again in the future without hesitation.”

—Staff Project Manager, bioMérieux, Inc.

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