Complaints Management within Medical Device Companies: Why Quality Leaders Must Gather Business Intelligence from Complaint Data

Whitepaper | July, 2021

Business leaders in the medical device industry often point out that every complaint is different and needs an appropriate response. By automating complaint management, categorizing the complaints and ensuring it is addressed suitably becomes easier. Additionally, end-to-end management of complaints driven by a seamless flow of information across the enterprise is a “must-have”.

By taking advantage of data and an artificial intelligence framework, complaint handling teams can automatically triage complaints based on risk level and urgency. Following the triage, a complaint is routed for further investigation and also evaluated for the need to report to a regulatory authority. Notifications are also automatically sent to the relevant departments and personnel, and escalation mechanisms are triggered based on the complaint’s severity and priority.

Manual and legacy systems that operate in silos are extremely inefficient and ineffective when it comes to managing complaints. One needs a next-generation solution that is truly integrated with the end-to-end product lifecycle. Right from intake of complaints to regulatory submissions to complaint resolution, an integrated automated complaint management solution can prove beneficial. An effective solution is one that will drive continuous improvement of the entire workflow, ensure all regulatory requirements are met, and proactively works to minimize risk.

In this whitepaper we deep dive into the world of Complaint Management for Medical Device companies.

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