Summary: Quest International has expanded its field corrective action (FCA) services, offering medical device OEMs scalable solutions for regulatory compliance. These FCA services are designed to handle increased recall demands efficiently and are backed by Quest’s rigorous Quality Management System.

Key Takeaways:

  • Quest provides OEMs with flexible, high-quality FCA support to meet regulatory timelines without compromising internal resources.
  • Quest’s FCA services are backed by robust ISO certifications, ensuring consistent quality and safety in medical device management.

Quest International, an 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.

As the FDA reports a steep increase in recall notices, OEMs are under more pressure to respond efficiently. 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.

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Quest’s Turnkey FCA Services

Quest’s enhanced FCA services offer OEMs a turnkey solution, delivering critical support in field services, logistics, repair, and rework. Designed to scale up or down as needed, Quest’s 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.”

Success in FCA Execution

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

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.