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Product quality and patient safety

Quality and safety are embedded from product design through post-market performance, supported by our systems and oversight.

How we reinforce quality

At Boston Scientific, quality and safety are integral to product design and prioritized throughout the product life cycle. We continue to strengthen our global quality systems to support rigorous standards, reliable performance and sustained stakeholder confidence.

  • Reinforcing our commitment to compliance: We continue investing in our global quality management system and compliance capabilities, enhancing governance, monitoring and sitelevel execution to maintain safety and quality standards.
  • Protecting product performance: We continuously reinforce the fundamentals of quality control and product performance across our operations, enabling reliable, high-quality medical devices for patients and healthcare providers.
  • Advancing digital quality systems: Digital tools integrated into our quality systems help improve precision and efficiency, enabling teams to identify and address potential issues more quickly and accurately.
  • Responding to product concerns: When potential issues are identified, we investigate and take appropriate action in patients’ best interests, including issuing product advisories and sharing information.
Learn more about our approach to quality and Best4 strategy here
  1. Represents GAAP R&D expense per Annual Report on Form 10-K.
  2. Represents GAAP R&D expense as a percentage of GAAP net sales per Annual Report on Form 10-K.