As Medical Device companies grow, significantly change their organization or evolve into several sites, the need often arises to modify the Quality Management Systems (QMS) 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 of designing a corporate Quality Management System to achieve compliance with QSR, ISO 13485, MDD, IVDD, AIMDD, CMDR, etc
Considerations of assigning authority and responsibility between corporate and local functions
Optimization of the QMS to improve its efficiency in a global operation environment
Creating roll-out plans for QMS changes
Temporary on-site staffing and support
Training of personnel
Contact me for further information Nils-Åke Lindberg
Office +46 46 286 88 90 or send me a mail