As medical device organizations develop over time the quality management system (QMS) needs to be modified accordingly.
The QMS needs to be both compliant and efficient in order to fully support the organization.
We support and help you with:
Planning of designing the quality management system to support the organization’s processes and meet applicable regulations and standards, such as ISO 13485, MDR, IVDR, 21CFR820, etc.
Inclusion of other relevant standards such as ISO 14971, IEC 62304, ISO 62366-1, etc.
Evaluate and suggest suitable digital platform for the QMS including digital signatures
GAP analysis for planned QMS changes
Creating roll-out plans for QMS changes
Optimization of corporate QMS covering multiple sites
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