The company sources raw materials, components, and finished goods for its facilities in California and from a contract manufacturer in Costa Rica that supports catheter production. Electronics such as generators and connector cables are produced by original equipment manufacturing partners according to the company's design specifications. The company relies on a limited number of suppliers for certain raw materials and components, typically ordering on a purchase order basis without long-term supply agreements, except for binding one-year purchase commitments with its catheter contract manufacturer. Finished products are shipped from the Santa Clara site to third-party logistics providers, hospital customers, or distributors. Some customers in various European countries receive products on consignment from a third-party logistics provider in the Netherlands. The catheter contract manufacturer ships products to the Santa Clara facility for inventory before distribution. The company maintains quality control and holds certifications including ISO 13485:2016, ISO 14001, compliance with the EU Medical Device Directive, the EU Medical Devices Regulation, and the Medical Device Single Audit Program certification covering multiple geographies. Internal audits and staff training support quality assurance, and the company undergoes periodic regulatory audits.
Shockwave Medical Inc's Comment on Supply Chain
The company sources raw materials, components, and finished goods for its facilities in California and from a contract manufacturer in Costa Rica that supports catheter production. Electronics such as generators and connector cables are produced by original equipment manufacturing partners according to the company's design specifications. The company relies on a limited number of suppliers for certain raw materials and components, typically ordering on a purchase order basis without long-term supply agreements, except for binding one-year purchase commitments with its catheter contract manufacturer. Finished products are shipped from the Santa Clara site to third-party logistics providers, hospital customers, or distributors. Some customers in various European countries receive products on consignment from a third-party logistics provider in the Netherlands. The catheter contract manufacturer ships products to the Santa Clara facility for inventory before distribution. The company maintains quality control and holds certifications including ISO 13485:2016, ISO 14001, compliance with the EU Medical Device Directive, the EU Medical Devices Regulation, and the Medical Device Single Audit Program certification covering multiple geographies. Internal audits and staff training support quality assurance, and the company undergoes periodic regulatory audits.
Sources:
Shockwave 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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