Feel confident standing behind your products. Access a global quality assurance network for help with product complaints, regulatory reporting, and inquiry support.
Patient safety, regulatory compliance, and customer satisfaction are the top priorities for every medical device company. You want to provide the best products possible to your customers. As distribution increases and business goes global, ensuring quality and compliance requires more rigorous post-market surveillance.
Post-market surveillance is the practice of monitoring the safety and effectiveness of a medical device once it is put on the market. More than quality assurance, post-market surveillance is concerned with meeting regulations and filing the proper reports with local authorities.
Wipro provides robust support for post-market surveillance, including end-to-end complaint management, regulatory/vigilance reporting (MedWatch forms, MIR, etc.), and thorough communication with local health authorities. Our globally distributed team has extensive experience managing product quality complaints in multiple languages, across therapeutic areas and various digital platforms. They are also skilled in filing regulatory documents (surveillance plans and reports, clinical and performance follow-ups, periodic safety updates), conducting health hazard evaluations (HHEs), managing device recalls and CAPA programs. Wipro processes complaints and regulatory/vigilance reports for more than 120 countries in 60+ languages.
Multilingual, across voice & non-voice channels (call, fax, email, chatbot, social media) from intake, investigation to closure
- Regulatory/vigilance reporting and submission to local authorities
MedWatch forms, MIR
- Regulatory document writing
Plans and reports for post-market surveillance and periodic safety updates
- Health-inquiry support
- Health hazard evaluation (HHE)
- CAPA management
- Device recall/return support
- Trend reporting
- Device tracking