Medical device manufacturers leverage Wipro’s expertise in quality assurance and regulatory affairs for improved device safety and effectiveness and reduced risks associated with non-compliance. Our first-hand working knowledge of global regulatory requirements and an in-house device testing facility helps balance compliance goals with market requirements.The service includes:

• Regulatory Consulting to bring down compliance cost through gap analysis, regulatory remediation and product registration
  
• Regulatory R&D for country-specific pre-compliance, verification, validation and certification, end-to-end risk management and design quality using our partnerships with UL, TUV and BIS
  
• Regulatory IT for comprehensive computer systems validation and regulatory compliance that covers Strategic IT Compliance Consulting, IT Compliance, CSV hands-on services and IT Infrastructure
  
• Our quality assurance and regulatory services result in minimizing product recalls, reduced legal costs and better patient outcomes