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 both compliant and efficient in order to fit the new organization’s needs. Currently the transition to ISO 13485:2016 needs to be addressed in many companies.
We support and help you with:
Strategic planning of designing a corporate Quality Management System to achieve compliance with QSR, ISO 13485, MDD/MDR, IVDD/IVDR, AIMDD, CMDR, etc. If desired, it can be cloud-based and if needed, it can contain Part-11 compliant digital signatures
GAP analysis for ISO 13485:2016 upgrades
Considerations of assigning authority and responsibility between corporate and local operations
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
Contact me for further information Nils-Åke Lindberg
Office +46 46 286 88 90 or send me an e-mail