Qualification of Contract Software Developers Based on Practical Experience

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    Speaker: Edwin Waldbusser

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    Duration: 60 Minutes
    Product Code: 50712
    Level: Intermediate

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This webinar will explain the regulatory requirements and a risk based procedure to qualify and manage Contract Software Developers (CSD) 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 speaker’s experience in qualifying contract software developers. Software development contract 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 selection process. The responsibility for product quality and safety remains with the company. It cannot be delegated to the software developer.


  • Risk determination method for Contract Software Developers (CSD)
  • Phases of selection
  • Developing the qualification 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 software development contract and quality agreement
  • Change approval by both CSD and company 


Learn about the qualification audit and selection process for Contract Software Developers (CSD). The webinar also explains the various regulatory requirements, and how to develop a software development contract and quality agreements.


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


Years of Experience: 30+ years

Areas of Expertise: Design Control, Risk Analysis and Software Validation of Medical Devices

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 US and internationally in the areas of design control, risk analysis and software validation for the past 9 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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