- Design control process execution, management and adherence throughout the project life cycle
- SolidWorks® Product Data Management(PDM) integration for design management
- ISO 13485:2016 compliance and Implementation
- Iterative and looped design review process to ensure confirmation against design input requirements throughout product development process
- A tailored product development process, structured and executed to meet the medical device regulations design control requirements
- Risk management application and adherence
- Medical device master file technical support
- Product transfer to manufacturer, documentation and management
- Design history file management and technical file creation