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Computer System Validation

Medical Device Manufacturer Computer System Validation

For new systems, validation starts when a user department has a need for a new computer system. For an existing system, it starts when the system owner gets the task of bringing the system into a validated state. Momentum has been supporting medical device manufacturers (MDMs) with CSV for over a decade. Through the validation process, we will provide you with:

Implementation of System

Quality Management

  • Compliance with a recognized Quality Management System (QMS) may provide the regulated user and regulatory agencies with the desired confidence in the structural integrity, operational reliability and on-going support for software and hardware products utilized in the system. This is very important for critical systems



  • One of the most critical aspects of software development is the integration testing phase where individual elements of software code are combined and tested until the entire system has been integrated.
  • The development and testing of hardware and software should be done under a quality assurance system, documented and formally agreed upon between the various parties.


Validation Strategy

  • Regulated users must provide evidence for their computerized systems to demonstrate their range, complexity, functionality, control and validation status. This enables the regulated user, and competent authority, to have a high level of confidence in the integrity of the processes executed.


Life Cycle Management

  • Ability to identify and realize cost savings through product or service life cycle.
  • Provide framework for anticipating future scenarios and helping businesses adapt ahead of time, not only to manage the risk, but to capitalize on the opportunities that it presents.
  • Product roadmap with external suppliers and manufacturers.
  • End-of-Life components
  • Last time buys
  • Product change notifications
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