MEDICAL DEVICE INDUSTRY · GERMANY
FDA Remediation - Medical Device
Challenge
Our medical device client in Germany received an FDA warning letter for a surgical device. The letter centered on quality system violations, specifically the risk of bacterial contamination, which required extensive remediation efforts. Products were subject to a refusal of admission into the U.S. until the violations were resolved.
Solution
Verena provided a Consultant team to work onsite in Germany to support corrective actions for design and manufacturing processes. Consultant team worked with the development team to re-engineer the device and update technical documentation including the Design History File, with a focus on Risk Management. Verena understood the critical nature of the support our client needed and moved quickly to provide a wide range of consultants with necessary product knowledge.
"I have worked with Verena for more than two years in support of <my company>’s global recruitment needs. During this time, they have successfully provided a number of permanent hires across Ireland, Germany, Switzerland and the United States, particularly for niche and difficult-to-fill positions where our internal Talent Acquisition team faced challenges. I have engaged them to source external contractors for a variety of projects and business requirements."
Result
Our client announced that it received a close-out letter from the FDA, concluding the remediation process and validating the corrective actions taken with the support of our team. Strategic agreement put in place between client and Verena for continued future support.
VERENA'S KEY ATTRIBUTES
● Providing consultants across a wide range of skills.
● Providing consultants with previous remediation experience.
● Response Speed & Understanding the critical needs of the client.
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