PureVision AI, Inc.
Information Technology & Services - Jersey City, New Jersey, United States
PureVision AI, Inc. Employees
PureVision AI, Inc. Details
PureFDA (a subsidiary of PureVision) helps streamline and ease supply chain constraints for personal protective equipment (PPE) due to COVID-19 by creating a global medical supply and PPE sourcing platform and regulatory approval consultancy. ➤ For PPE Manufacturers:Our network of regulatory experts provide one-stop, full-service guidance through the application and certification process to gain regulatory approvals for distribution in new international markets in the U.S. as well as throughout the European Union, Canada, Brazil, India, South Korea, and Russia. We also provide services including:• Registered Initial Importer Status – We partner with customs brokers and manufacturers as an authorized, registered initial importer with the FDA, where we monitor the end-to-end import and distribution process for medical device and PPE manufacturers. • U.S. Agent Services – We serve as the registered U.S. Agent, a requirement by the FDA for foreign manufacturers, for 40+ companies worldwide. • Product Testing – We connect overseas manufacturers with U.S. laboratories and manage the end-to-end product testing process.➤ For PPE Buyers:Since the COVID-19 outbreak, we've found that buyers have been bombarded with options to buy PPE products and picking a supplier has become a daunting and risky task for many. To help overcome this issue, our team at PureFDA has compiled a free list of vetted products and manufacturers that meet advertised specifications. We also launched a database to help buyers identify reputable PPE manufacturers based on local regulatory requirements. Check out https://check.purefda.com/ to see if your PPE is compliant. As a company born out of the pandemic, we are committed to doing everything we can to help. This includes donating:• 6,000+ hours of volunteer time to help connect buyers with reputable suppliers. • Thousands of respirators to the V.A. Medical Center in the Bronx.
