• Pre-assessment & Mock Audits
• Internal Audits (FDA, QSR, MD-SAP,
ISO 13485)
• Auditor Training
• Supplier Audits
• EU CE Certification
• Medical Device Single Audit Program (MD-SAP)
• US FDA 510(k) Process
• US FDA PMA Process
• US FDA 483 Mitigation
• Creating a Quality Management System
• Developing a Global Regulatory Plan
• Planning a Quality System
• Risk Management: An Elegant Solution Device Safety
• Software as a Medical Device (SaMD)
• IEC 60601-1 ed. 3.2: Medical Device Safety
• Corrective Action/Preventative Action System (CAPA)
• Complaint Management
• Supplier Quality Management
• Process Validation
• Root Cause Analysis
• Writing Standard Operating Procedures (SOPs)