Quest International's Expanded FCA Resources Offer Medical Device OEMs Timely, Reliable Support Amid Rising FDA Recalls
IRVINE, CA / ACCESSWIRE / November 12, 2024 / Quest International, the leading integrated service and support partner for Medical Device Original Equipment Manufacturers (OEMs), has expanded its resources in Field Corrective Action (FCA) services to meet the industry's rising regulatory demands.
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As the FDA reports a steep increase in recall notices - 296 Class I recalls in Q1 2024 alone, marking a 13.8% rise over the previous quarter - medical device OEMs are under more pressure than ever to respond efficiently. With over 32,000 devices recalled since 2012, partnering with a trusted provider for timely and precise FCA execution is a top priority for many OEMs.
In recent months, several high-profile recalls have underscored the logistical and operational challenges that medical device OEMs face when executing large-scale corrective actions. For OEMs, finding a partner with the experience and resources to handle these demands can make the difference between a smooth FCA process and costly delays.
Quest's enhanced FCA services offer OEMs a robust, turnkey solution, delivering critical support in field services, logistics, repair and rework. Designed to scale up or down as needed, Quest's highly trained teams provide OEMs with the flexibility to meet regulatory timelines without diverting internal resources. This collaborative approach allows OEMs to maintain focus on their core innovations and customer relationships.
"Today's regulatory environment demands both precision and speed in every Field Corrective Action," said Shawn Arshadi, President and CEO of Quest International. "Quest has been the trusted partner for OEMs for 40 years, delivering seamless corrective action solutions that meet the highest standards in quality and compliance. We take pride in enabling our partners to respond to these challenges swiftly and confidently, knowing that we will execute with accuracy and reliability they expect."
Quest has completed a multitude of FCAs for major medical device OEMs, both small and large. One FCA involved remediating devices with the following scope:
Performing the FCA on 12,000 affected devices at 180 sites
Meeting a completion rate of at least fifteen devices per day
Achieving a failure rate of less than two percent
Adhering to a strict per-device budget
Completing the entire project within five months
"Our team's ability to exceed expectations ahead of schedule and within budget is a testament to Quest's scalable processes and our rigorous Quality Management System," added Arshadi. "Our commitment to excellence in every FCA project ensures that OEMs can maintain compliance, protect their brand reputation, and deliver safer, more reliable products to their end-users."
Quest's FCA offerings are reinforced by one of the industry's most rigorous Quality Management Systems (QMS), backed by ISO certifications that include ISO 9001:2015, ISO 13485:2016, ISO 14001:2015, and ISO 27001:2022, along with ANSI/ESD S20.20-2021 registration for ESD safety.
Contact Quest International today to ensure your Field Corrective Actions are completed with speed, accuracy, and regulatory compliance.
About Quest International
Quest International is the leading global aftermarket integrated service partner for Original Equipment Manufacturers (OEMs) across multiple industries, as well as an IT-managed services provider for emerging and enterprise businesses.
Contact Information
Aaron Schmidt
Marketing Manager
communications@questinc.com
949-581-9900
SOURCE: Quest International
View the original press release on newswire.com.
