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Millstone Medical has been securing medical device distribution licensing in all states that require the licensing. In addition, Millstone Medical has instituted a robust program for the continuous monitoring of requirements for the two types of licenses, direct to patient and wholesale distribution, in 50 states. Millstone, outsource partner to the nation’s top orthopedic companies, is the fast-growing provider of advanced inspection, clean room packaging, loaner kit processing, and distribution services to medical device manufacturers worldwide.
The impetus for development of the service was the complexity of licensing requirements, which differ from state to state. Some states require a simple application, while others include finger printing of senior leaders and background checks, certification of designated representatives, surety bonds, and Verified-Accredited Wholesale Distribution (VAWD) accreditation. In addition, the processes and timeframes for renewal are state dependent and the regulations governing medical device distribution are regularly reviewed and updated.
The difficulty in gaining and maintaining the necessary licenses results in regulatory difficulties and high costs. From licensing fees to redirection of key personnel to manage the licensing process, cost becomes a major challenge that Millstone helps manufacturers overcome. Millstone’s offering is designed to deliver streamlined distribution, reduced costs, and increased speed to market.
“Distributing medical devices, even those used at home to improve circulation or enhance mobility after surgery, requires licensing in most states. The licensing process, though, can be onerous for device manufacturers,” said Chris Ramsden, Chief Executive Officer of Millstone Medical Outsourcing. “Our goal is to remove obstacles for our customers and to help them get their products to market faster. Our licensing, in conjunction with the federal and state requirements, allows our OEM partners to address regulatory hurdles and significant costs without cutting corners on quality.”