Confidence Beyond Compliance
Strategy (Plan)
- QMS gap assessment
- Compliance strategy
- Site quality plan
- Communication plan
Synergy (People)
- Organizational design
- Quality culture activities
- Inspection / Audit readiness (QSRs / QSIT, ISO13485 / MDSAP)
Optimize (Performance)
- Process and product quality metrics
- Compliance maintenance (including training, annual auditing, regulatory reporting / filing)
- Post-market surveillance reports
- CAPA effectiveness
- Actions from regulatory intelligence monitoring
Operation (Process & Product)
- Documented quality management system (QMS)
- Technical documentation (DHF / CERs)
- QMS implementation (including training, validation of tools-CSV)
