Corporate / Global QA
As Medical Device companies grow, significantly change their organization or evolve into several sites, the need often arises to modify the Quality Management Systems accordingly
The QMS needs to be compliant as well as effective in order to fit the new organization's needs.
We support and help you with:
- Strategic planning discussions early in the initial phase design process of designing a corporate quality management system to achieve compliance with QSR, ISO 13485, MDD, CMDR
- Considerations of assigning authority and responsibility between corporate and/or local functions
- Optimization of the QMS to enhance its efficiency in a global operation environment
- Support in creating roll-out plans for QMS changes
- Temporary on-site staffing and support
- Training