Core competencies include:
- Global regulatory strategy
- Global regulatory submissions
- Technical documentation EU MDD/MDR; IVDD/IVDR
- Regulatory and cultural intelligence
- Risk Management
- Agency meeting packages and participation
- CMMI and MDDAP
- Quality Management Systems
- Quality Management Representative and Persons Responsible for Regulatory Compliance
- Regulatory and Quality expertise for cross-functional teams
- Regulatory and Quality gap assessments for commercial and lab-developed tests
- Labeling and Promotional material review
- Post-Market Surveillance
