Comprehensive Postmarket Surveillance is more than receiving complaints and reporting to Regulatory Agencies.
Consider a scenario where there is reason to believe a distributed product no longer fulfills requirements and the firm is obligated to take measures to either repair, correct, or recall distributed product in order to prevent use and eliminate subsequent patient or user harm. Or a situation where a product was exposed adverse environment conditions in the distributions network? But how does the firm locate all of the product in the field? How do they manage communication with Agencies and customers?
Manufacturers must gain insights from critical data to track key considerations, including:
- Distribution, use, and tracking data helps to identify where a product is but requires overhead or structure to manage
- Consistent and compliant response to impacted product that is already in distribution (e.g. recall, removal, corrective action, or withdrawal)
- Communicate with customers, distribution partners, and regulators
- Analysis of communication and product tracking data to reconcile and close recalls and market actions effectively and expeditiously.
Join this webinar to learn how to assess your postmarket surveillance program and distributed product tracking systems and how Honeywell is tackling this issue.
