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WinSoft specializes in the design of testers, software and complex test fixtures for the validation and testing of medical devices. We have over 10 years experience delivering test solutions to major medical device manufacturers.
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For reliability purposes, we are using our years of expertise in the medical and aerospace fields, to provide self test adapters which assure the reliability of the testing platforms. In addition, we are using a variety of tools from National Instruments, which significantly increases the reliability of our systems:
  • Requirements Gateway - a requirements traceability tool. It performs coverage and impact analysis, graphically displays coverage relationships, and generates comprehensive reports.
  • If LabVIEW is used, we are performing static code analysis with LabVIEW VI Analyzer Toolkit.
  • For Design Validation, around National Instruments hardware, we are using Hardware-in-the-Loop (HIL) simulation
     
Our testers, software and fixtures cover medical device such as:
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  • Pacemakers
  • Micro-pumps
  • Knee Braces
  • Cold Therapy Unit
  • Invasive medical devices
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If required, FDA quality assurance (QA) process or good manufacturing practice (GMP) (i.e. CFR21 ) are used  via coordination with our customers. Our test code is subject to the same scrutiny with regards to development practices, change management, and documentation based on our ISO 9001:2008 system and version control system.

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