Sustaining Engineering Support

CooperSurgical, Inc. is a leading company dedicated to providing medical devices to the women’s health care segment. Their diagnostic and therapeutic products for clinicians address a wide spectrum of women’s health issues in surgical, clinics/offices, labor & delivery and critical care areas, delivering improved clinical outcomes.

 

Services Provided by Sparton:

CooperSurgical was looking for a trusted partner to provide ongoing software and sustaining engineering support for their products over their extended life. Sparton, whose capabilities include sustaining engineering and a proven process for efficiently transferring software product support, provided an onsite review of the software and documentation for each of the initial five products requiring support. Subsequently, repositories were created, respective development environments replicated, and product baselines were verified for each product. The scope of work included:

  • Upgrade products to run in 64-bit Windows environment
  • Execution of formal verification testing before each software release
  • Enhance DICOM functionality to provide easier integration with other hospital systems
  • Address equipment/parts obsolescence issues
  • Upgrade products for Windows 8 and Windows 10 environments
  • Provide documentation to address customer security concerns to support sales staff efforts
  • Improve products to support the newly adopted ICD 10 medical classification codes
  • Provide gap analysis on the product documentation to identify areas of weakness
  • Enhance the design control documentation

Key Challenges:

  • Fully replicate the unique software build environments for each product
  • Identify missing product knowledge due to loss of key resource at CooperSurgical
  • Become the product expert to quickly meet product delivery timelines
  • Resolve configuration management issues to establish each product’s software baseline
  • Review various versions of Windows and Microsoft development tools to generate an efficient plan for delivery
  • Enhance the Design History File (DHF) documentation to facilitate compliance with the latest regulatory guidelines
  • Assist CooperSurgical’s major end customers with their integration and upgrade needs

 

End Result:

Sparton’s quick response and efficient use of resources to make timely deliveries, extended the life of each of CooperSurgical’s products resulting in increased revenue. The DHF documentation was improved to support a potential FDA resubmission or audit. Positive project results, and high customer satisfaction, resulted in additional products being brought under Sparton’s umbrella of support, including leading the software development effort in new products.

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