QUALITY SYSTEM REGULATIONS (QSR)
• All Medical Device Compliance Activities
• All FDA Compliance Activities
• U.S. Agent Services
• Official Correspondent Services
• GMP/Quality System Procedures
• Submissions, 510 (k) and PMA
• FDA Inspection Readiness and Response
• Warning Letter Responses
• Medical Device Reporting Activities
• Audits, Internal and Supplier
• FDA Compliance Training
• Surveys, Client and Marketing
• Documentation Management System
• CAPA (Corrective And Preventive Action) System
• Change Control and Management System
• Quality Review Process
• Design Control Process
• Validation System
• Validation plans, protocols and related documentation
• Internal Audits
• Supplier Quality Audits
• Quality plans, procedures or manuals
• Contract Manufacturer Quality Inspections
• Customers Complaints System
• Risk Management approaches & strategies
• cGMP Process
• Quality System approaches (cGMP/QSR - 21 CFR Part 820 and ISO 9000)
• Documentation System
• Validation for process, cleaning and equipments (21 CFR Part 210, 211 and 58)
• Risk Management Strategies (cGMP and QSR)
• Six Sigma approaches for cGMP quality
• Supplier Quality Audits
• Validation for computer systems (21 CFT Part 210, 211 and Part 11)
• Software Quality Engineering
• IT Quality & Compliance issues
• Network System Qualifications