Software used in medical devices, as well as software used to design, develop or manufacture medical devices, must be validated for its intended use, as required by the Quality System Regulation, 21 CFR Part 820. This requirement applies to any software used in medical devices or to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, or to automate any other aspect of the quality system. Such software may be developed in-house, under contract, or purchased off-the-shelf for a particular intended use. All must be validated for each specific use.

All product, production and/or quality system software must have documented requirements which fully define its intended use, and against which testing results and other verification evidence can be compared, to show that the product, production and/or quality system software is validated for its intended use. Regulatory Specialists, Inc. can provide the following services:

Software Related Services

  • Software Description
  • Hazard Analysis
  • Requirements Specification
  • Validation
  • Verification
  • Testing
  • Software Validation Reports