Quality management systems
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
- Personnel training
Contact me for further information
Office +46 8 621 01 05 or send me an e-mail