Recalls happen to even the most diligent companies and the impact on business is often underestimated. As the regulatory landscape continues to evolve, MedTech companies need a customized plan that can be implemented with speed and accuracy on a global scale.
IQVIA MedTech offers a global, flexible outsourced solution that supports in the management and execution of your recalls and field actions.
When a Field Safety Corrective Action (FSCA) or medical device recall is triggered, speed and regulatory alignment are paramount. But navigating shifting global rules while managing manual notifications, tracking responses, and coordinating physical device remediation can quickly overwhelm your internal quality and service teams.
Whether you need rapid deployment of an on-demand remediation team or comprehensive medical device recall services wrapped into a global field action strategy, IQVIA MedTech minimizes business disruption. We deliver the strategic partnership and tech-forward frameworks required for seamless medical device crisis management — protecting both your users and your bottom line.
Is your business able to respond proactively to recalls? Are your teams prepared to respond with speed and agility?
IQVIA MedTech’s customized approach executes recalls and field actions quickly and accurately without overburdening your teams. With a dedicated, 3,500-strong global recall team, our service solution builds global execution teams for each step of the recall, incorporating an automated recall platform to track every activity to support your recall planning and enable you to respond with agility.
A global ophthalmology manufacturer faced a critical recall of faulty laser fibers, requiring removal and destruction of affected products across 44 countries. Due to regulatory pressures, the company needed a structured, efficient, and compliant recall process.
The manufacturer’s faulty laser fibers posed potential risks to patients, prompting a Class 2 recall as designated by the FDA. This meant the issue, while not immediately life-threatening, still required urgent attention to prevent long-term harm.
The recall needed to be executed at both consignee and distributor levels, ensuring all affected devices were accounted for and removed from circulation. Given the global scale of the recall, the company required a structured program to ensure regulatory compliance, proper notification of consignees, tracking of returned products, and certified destruction.
Despite the urgency of the recall, the manufacturer lacked the necessary logistics, communication infrastructure, and regulatory expertise to efficiently handle product removal across multiple regions.
IQVIA MedTech provided a customized Global Recall & Field Action Program, implementing structured communication, tracking, and logistics support to ensure a successful and timely recall.
The structured recall program led to a 96% response rate, full regulatory compliance, and on-time completion of the recall across all 44 countries.
Advance audit readiness, complaint handling, and post-market surveillance. Our expert MedTech teams, through strategic design, expert oversight, and proven risk mitigation, design quality assurance and compliance programs that meet stakeholder standards.
Turn data, strategy, and execution into measurable MedTech market success - faster launches, stronger adoption, and sustained performance.
