Device Recall, Corrections and Removals

Minimize Risk. Maximize Compliance. Maintain Trust.

When device issues arise, swift, strategic action is crucial. Freyr provides end-to-end support for medical device recalls, corrections, and removals, helping you meet global Regulatory requirements with confidence. From Regulatory communication and health hazard evaluations to customer notifications and device return management, our experts ensure every step is compliant, efficient, and transparent.

Because in critical moments, you need more than just a process, you need a partner.

Device Recall, Corrections and Removals Overview

Recalls generally involve pulling affected devices from the market to protect public health and safety. They can be voluntary or mandatory and are initiated due to regulatory violations. We offer end-to-end medical device recall management to ensure timely, compliant, and efficient resolution of product issues.

Corrections aim to resolve issues and reduce the risk without removing the device from the market. Removals, on the other hand, signify a complete discontinuation of a device due to safety or performance concerns and can be part of routine maintenance or upgrades.

At Freyr, our team of experts helps you navigate unforeseen Regulatory challenges with minimal disruption, offering support across critical activities like Health Hazard Evaluation Reports, Field Safety Notices (FSN), Field Safety Corrective Action (FSCA) reporting, Vigilance reporting, Good Faith Efforts, Customer Letters, Language Translation, and Intelligent Dashboard Reporting to ensure compliance.

Our goal is to minimize disruption, ensure swift action, and uphold your commitment to patient safety

Device Recall, Corrections and Removals Expertise

  • Health Hazard Evaluation Report
  • Field Safety Notice (FSN)
  • Field Safety Corrective Action reporting (FSCA)
  • Vigilance reporting
  • Good Faith effort
  • Customer letter
  • Intelligent dashboard reporting
  • Language Translation
  • Dedicated SMEs
  • In-depth product and Regulatory knowledge and expertise to understand complex device issues and identify underlying problems
  • Seasoned PMS experts ensure consistent complaints investigation process
  • Flexibility in the team to handle volume fluctuations
  • Experience across a wide range of therapeutic areas and digital platforms
  • Expert translators and language specialists simplify complex technical jargon

Why Partner with Freyr?