The company utilizes high-precision, computer-aided manufacturing equipment and has established a primarily domestic supplier base to facilitate collaboration during product development. Suppliers are selected through a formal vendor approval process and must comply with internal quality assurance standards, including ISO-13485 certification for implant providers. The company sources allograft tissue implants for its Osteocel Plus and Osteocel Pro product lines from several tissue banks, which are subject to strict quality criteria and regulatory compliance. It also works with a limited number of suppliers for components of its Enabling Technologies and IONM platforms, maintaining redundancies for critical components. Supplier performance is managed through qualification, performance management, corrective action programs, and periodic audits. The company and its third-party manufacturers adhere to FDA, state, and international regulatory quality system regulations. For tissue products, the company is FDA-registered and holds licenses in multiple states, including California, Delaware, Florida, Illinois, Maryland, New York, and Oregon.
Globus Medical Inc's Comment on Supply Chain
The company utilizes high-precision, computer-aided manufacturing equipment and has established a primarily domestic supplier base to facilitate collaboration during product development. Suppliers are selected through a formal vendor approval process and must comply with internal quality assurance standards, including ISO-13485 certification for implant providers. The company sources allograft tissue implants for its Osteocel Plus and Osteocel Pro product lines from several tissue banks, which are subject to strict quality criteria and regulatory compliance. It also works with a limited number of suppliers for components of its Enabling Technologies and IONM platforms, maintaining redundancies for critical components. Supplier performance is managed through qualification, performance management, corrective action programs, and periodic audits. The company and its third-party manufacturers adhere to FDA, state, and international regulatory quality system regulations. For tissue products, the company is FDA-registered and holds licenses in multiple states, including California, Delaware, Florida, Illinois, Maryland, New York, and Oregon.
Sources:
Globus Medical Inc 's official press releases and regulatory filings; CSIMarket.com's supply-chain research; and the financial filings and press releases of other companies cited in this report.
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