Services

Complaint Management & Backlog Reduction

- Root cause analysis
- Reportability review
- Remediation strategy

Audit Readiness & CAPA Support

- Internal audits (FDA, ISO-9001, ISO-13485, ISO-14971, Health Canada)
- Corrective action planning
- Backroom audit support

Regulatory Compliance & Risk Analysis

- FMEA, Hazard Analysis
- CE Mark & MDR prep
- SOP writing & process development

Compliance Training

- Onboarding modules
- Custom workshops for QA/RA teams