Quality and Regulatory Affairs
Lumos employs a qualified in-house quality and regulatory affairs team with experience in global IVD/Medical Device test development and planning, strategy, submissions, and quality management systems in accordance with international standards and good manufacturing practices (GMP)
- Global regulatory strategy
- Global regulatory submissions
- Technical documentation EU MDD/MDR; IVDD/IVDR
- Regulatory and cultural intelligence
- Risk Management
- Agency meeting packages and participation
- 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
