The medical device industry is experiencing a heightened need for effective complaint handling due to increasing hazards from serious reactions and public threats. Regulatory bodies now enforce stringent timelines for submitting complaints, especially those involving serious public health threats, deaths, and significant events. Additionally, the growing awareness of evolving regulations and multiple sources of complaint reporting are shaping the industry landscape.

Manufacturers face challenges such as handling large volumes of complex complaints, ensuring timely communication, managing complaints across various channels, and maintaining regulatory compliance. Efficient data management and analysis are also critical for deriving meaningful insights from complaint data.

Tata Elxsi addresses these challenges by offering end-to-end complaint management services tailored to meet specific strategic and financial needs. Our solutions significantly reduce manual efforts and costs while providing 24/7 operational capability and regulatory expertise, ensuring comprehensive support for medical device complaint handling, processing and compliance.