Systelab Quality Assurance

Range of Services Offered

• Quality Assurance outsourcing
• Audit, Action Plan, Follow-up


• Verification & Validation outsourcing
• Software Risk Analysis 
• Human Factors 
• Test Management, design, execution 
• Test automation 
• Traceability
• Acceptance test 
• OTS Software Validation


• Independent Verification & Validation 
• Parallel independent test, risk management
• Support for Acceptance test (IQ/OQ/PQ) 


• Assessment for Process Improvement 
• Process Assessment, Action plan
• Quality System definition, roll-out 


• Assessment for Vendors Qualification 
• Vendor Assessment 
• Clinical Product Assessment 


• Consultancy for FDA submissions, CE Mark and certifications with other regulatory bodies 
• Process and Product Audit 
• Support development of Technical Documentation for submission 


• Quality Assurance Training 
• About Regulation & Standards 
• About Quality Systems 
• About Testing Process 
• Theory and Practice