Quality is becoming more and more important in today’s medical device and combination products industry. Companies need to make sure they have the right quality resources on board and that quality is fully integrated into their culture.
- Creation of Quality Systems in compliance with ISO 13485
- FDA 21 CFR Part 820, 210, and 211
- Quality System and DHF Audits; 483
- Warning Letters, and Deficiency Responses
- Audit Preparation
- Audits
- Quality System Gap Analysis
- Quality Management System Remediation
- Validation
- Post Market Surveillance
- Complaint Code Mapping
- CAPA
- Merger and Acquisition Quality System due diligence