Design Control
The regulations of today demand that all design and development is carried out as a controlled and documented process
The design control process involves verification and validation of the design which has to be considered up front. The regulations assume user requirements as foundation for the design and that these are traceable throughout the development process and finally fully validated.
We can help you assess your design process:
- Establishment and Implementation of the development model
- Planning and adaptation of design control procedures
- Quality assurance of development projects
- Design documentation audit
- Independent design review
- Risk management
- Regulatory strategy
- Training