Rigorous clinical science underpins our product breakthroughs. We generate high-quality evidence, leveraging advanced internal testing methodologies, diverse and representative real-world datasets and collaborations with global research partners.
Pre-clinical excellence
• Before progressing to human trials, we conduct rigorous pre-clinical research to confirm the safety, efficacy and performance of our devices. Our teams follow the highest standards in training, testing and regulatory compliance, publicly reporting research outcomes and submitting findings to regulators.
• Continuous safety monitoring begins at the product design stage and extends throughout development to help ensure our technologies meet the highest safety and quality standards.
Ethical research and patient safety
- We design and execute rigorous clinical trials in collaboration with external experts and regulatory bodies to document the safe and effective performance of our products.
- Patient safety and ethical research standards remain central throughout the process, with continuous monitoring and ongoing evaluation to help ensure our innovations deliver meaningful benefits for patients, providers and payers.
Animal welfare and alternative methods
- We are committed to the humane care and treatment of laboratory animals and follow the Three Rs — Replacement, Reduction and Refinement — to minimize animal use wherever scientifically feasible.
- Boston Scientific is accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) and is routinely audited by internal experts and regulatory agencies, including the FDA and the U.S. Department of Agriculture. Through our Pre-Clinical R&D Center of Excellence for Biological Innovation, we continue advancing in-vitro and alternative testing methods to supplement animal research while maintaining the highest regulatory standards.