+972-4-9895914 info@meddev-design.com

Med-Dev Design offers its customers with comprehensive consulting for software verification & validation as well as medical device software quality assurance (SQA).

Our software regulation services include:

45
FDA Approvals for the last 6 months done by our expert SQA team
  • Software Verification and Validation (V&V) according to FDA/CE requirements
  • Risk, safety and hazards management
  • Software development life cycle procedures, templates and forms
  • Documentation of the software development process – which is verified and validated to ensure that R&D team fulfills all regulatory requirements.
  • Preparation of all necessary documents for FDA/CE submission
  • Monitoring of the software quality system and testing the applications
  • The following issues are also covered in the SQA Procedure: Design reviews, Unit testing, Integration testing, Verification testing, Static analysis, Code reviews, Code control, Bug tracking