Quality Assurance and Regulatory Affairs

Increased regulatory scrutiny is making it imperative for Medical Device manufacturers to turn to technology in order to identify cost-effective methodologies that assure safety, increase device effectiveness, reduce risks associated with non-compliance and increase speed to market. Attention to quality and regulatory requirements are becoming critical in the Medical Device industry as a means to minimize product recalls and legal costs while meeting patient health goals.

How Wipro Helps

Wipro collaborates with Device Manufacturers to meet their compliance goals. We also balance those goals with market requirements, innovation, costs and business growth in pre-market, manufacturing and post-market areas.

Our regulatory services include:

  • Regulatory Consulting
  • Regulatory R&D Services
  • Regulatory IT Services

We have first-hand working knowledge of global regulatory requirements and an in-house world class facility for testing Medical Devices. Our resources have multi-dimensional skill sets to solve and support your regulatory, quality and IT compliance needs.

  • Regulatory Consulting

    domainExperts

    An effective regulatory strategy can give Medical Device companies a competitive edge as regulatory requirements become more stringent and compliance costs go up. We offer end-to-end Regulatory Consulting Services.

    Our offerings include:

    • Regulations/standards gap analysis and implementation of recommended roadmap
    • Regulatory Remediation
    • Product Registration

    Regulatory R&D

    We offer end-to-end Regulatory R&D Services as we partner with UL, TUV and BIS. Our services meet global standards and country-specific regulatory requirements.

    Our offerings include:

    • Pre-compliance, Verification and Validation and Certification
    • End-to-end Risk Management
    • Design Quality

    Regulatory IT

    We offer complete and comprehensive Computer Systems Validation and Regulatory Compliance Services across the globe. Our services meet global standards and ensure system accuracy, reliability and consistent performance, while reducing compliance risks.

    Our offerings include:

    • Strategic IT Compliance Consulting
    • IT Compliance
    • CSV hands-on services
    • IT Infrastructure Qualification