BSI Product Services

BSI (British Standards Institution) is a global standards and certification body that serves as a critical infrastructure provider for the life sciences and healthcare industries. As a leading Notified Body, BSI provides essential regulatory oversight and certification services for medical devices and in vitro diagnostics (IVDs) to ensure compliance with EU MDR and IVDR requirements. The company offers quality management system certification, specifically ISO 13485, which is the gold standard for the medical device industry. BSI also provides product testing, technical documentation reviews, and clinical evaluation assessments to help manufacturers secure market access. Their expertise spans a wide range of technologies, from high-risk implantable devices to digital health software and diagnostic kits. Through its training and advisory services, BSI supports pharmaceutical and medtech companies in maintaining global safety and performance standards.