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:
- 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