- Quality manuals and quality systems implementation
- Quality Suite Development – GXP, GLP, GMP, QSR, ISO 13485, ICH
- Liaison to the FDA (Meeting preparation, submissions and FDA response)
- Liaison to International Notified Bodies
- Compliance training programs (ISO, GXP, GCP, MDR, IVDR)
- Internal and Supplier audits (Compliance, CE Mark, CAPA verifications, MDSAP)
- Supply Chain Management
- MDSAP and Remote Auditing systems for compliance
- CE Mark compliance development
- Corrective Action/Preventive Action (CAPA)
- Dodd-Frank: Conflict Free Metals
