Introduction Transforming care Investing in our people Accelerating possibilities Protecting the environment Creating value responsibly Appendix Topic Accounting Metric Code Response The company's commitment to innovation and patient health extends beyond the surgical suite by managing the environmental and human health impact of chemicals in our products Discussion of process to assess and manage environmental through design, manufacture and use. Our design and supplier management processes assess and human health considerations associated with chemicals in HC-MS-410a.1 and manage relevant environmental and chemical requirements. We work with our suppliers products, and meet demand for sustainable products to ensure material compliance of all purchased goods and components, allowing us to make Product Design & responsible material and chemical choices for the design and manufacture of our products. Lifecycle Management Performance Report, Enhancing product stewardship, Page 46 Within participating customers: Total amount of products accepted for take-back and reused, • 97% of LithoVue™ systems recycled in the United States in 2022 recycled, or donated, broken down by: (1) devices and equipment HC-MS-410a.2 (2) supplies • 97% of EXALT™ Model D systems recycled in the United States in 2022 Performance Report, Enhancing product stewardship, Page 46 All Boston Scientific medical device manufacturing facilities are audited by external regulators or applicable authorities. All of our medical device manufacturing facilities and distribution centers are certified under the ISO 13485 quality system standard, established by the Percentage of (1) entity's facilities and (2) Tier I suppliers' facilities International Standards Organization (ISO) for medical devices, which includes requirements participating in third-party audit programs for manufacturing and HC-MS-430a.1 for an implemented quality system that applies to component quality, supplier control, product product quality design and manufacturing operations. A majority of our direct suppliers are ISO certified (for example ISO 9001 or ISO 13485), as applicable, and demonstrate compliance and quality through certification audits. Form 10-K, Item 1. Medical Device Regulatory Approvals, Page 9 Supply Chain Boston Scientific maintains traceability within the manufacturing and distribution chain through Management either serial or batch control of finished products. We: • Leverage product identification technologies, such as barcoding identification to track the Description of efforts to maintain traceability within the HC-MS-430a.2 information of products distribution chain • Utilize enterprise resource planning (ERP) solutions to support identification and control of products once they leave manufacturing sites — including supporting specific patient tracking if required. Our ERP solutions ensure compliance with regulatory, quality and customs control requirements Description of the management of risks associated with the use of HC-MS-430a.3 Form 10-K, Item 1. Manufacturing and Raw Materials, Page 8 critical materials Performance Report, Creating value responsibly, Page 47 76 2022 Performance Report
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