QMS Services
From MDR gap analysis to SOP review, internal audits and CAPA — continuous support for MDR-compliant quality management.
Typical challenges
- Unclear whether your QMS meets MDR requirements
- Heavy workload maintaining SOPs and documentation
- Internal audits and CAPA tend to become box-ticking
What we provide
- MDR gap analysis
- Identify gaps between your current QMS and MDR requirements
- SOP review & documentation
- SOP review and documentation structure
- Internal audit support
- Planning and conducting internal audits
- CAPA support
- Operating corrective and preventive actions
How we work
- 1Gap analysis
- 2Improvement planning
- 3SOP development & operation
- 4Internal audits & continuous improvement
Related services
Start with a free 30-minute consultation
We help you map your current position: device class, CE status, and EU clinical investigation plans.
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