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This webinar will explain the regulatory requirements and a risk based procedure to qualify and manage suppliers that develop software for your company. The phases of the selection process, from compiling a list of candidate developers through the qualification audit and final decision, will be explained. This process is based on the regulations and the authors experience in qualifying contract software developers. Contracts and Quality Agreements will be described in detail.


Regulatory agencies require that companies carefully select suppliers and contract software developers (CSD). They must follow a carefully planned and documented procedure. The responsibility for product quality and safety remains with the company. It cannot be delegated to the software developer.


  • Contract Software Developer risk determination method
  • Phases of selection
  • developing the audit; key stakeholder issues
  • Conducting the audit; key points to evaluate


  • Decision factors for selection; key practical points
  • Reasons for not using a numerical scorecard to make a decision
  • Key points for the contract and Quality Agreement
  • Change approval by both CSD and company


  • Computer system developers
  • Systems development engineers
  • QA/ QC
  • Lab Managers and Analysts
  • Production Managers
  • Engineering managers


Edwin Waldbusser, is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.

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