Hello Roger. ComplianceAcuity would be glad to assist. We routinely set up OUS firms for timely, efficient, and compliant importation of their devices into the U.S., by advising and/or setting them up regarding key requirements such as FDA QS Regulation (soon to be QMSR) QMS setup and QMSR gap assessments, FDA registration and listing, initial importation, UDI / GUDID registration, eMDR readiness/support and subsequent tasks like internal auditing, FDA inspection support, and 510(k) maintenance. You may reach me at info@complianceacuity.com to learn more.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 11-Jan-2024 10:05
From: Roger Cepeda
Subject: Swedish device firm seeking US importation help
On behalf of a small Swedish manufacturer of Class II devices (mainly consumable/disposable blood products), I would like to hear from consultants who can help with the process of importing their products to the United States. They have received 510(k) but need guidance on the rest of the work needed to sell in the US.
Please respond here or email me direct at roger@medtech.law
Thank you
Roger
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Roger Cepeda, JD, MBA, RAC
MedTech Law LLC
roger@medtech.law
Mobile: 847-421-8361
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