Global market access for US medical device manufacturers

BSI is the world’s first national standards body partnering with medical device manufacturers to provide impartial third-party standards based assurance, compliance, information solutions, and training. Backed by 80,000 client locations in over 100 countries, and more than 50 BSI offices, we are the trusted partner of Industry and Government professionals all over the world.

By working with BSI America, medical device manufacturers are choosing to seamlessly access global in-house experts with regulatory experience in a wide-range of product and technical areas. Our experts have extensive hands-on experience in all aspects of the product life cycle including research and development, manufacturing and quality assurance.