BSI Group is the UK’s national standards body and a global provider of assurance and certification services. In healthcare, it is known for medical device regulatory services, including audits and conformity assessment against relevant quality and safety standards.

Healthcare services

BSI supports manufacturers with certification, testing coordination, and technical review in areas such as quality management and device compliance. Training courses and guidance help organizations interpret regulations and implement robust processes.

Trust infrastructure

Operating across multiple regions, BSI combines standards development with independent assessment activities. Its services are used by device makers and supply-chain partners to demonstrate compliance, improve documentation discipline, and support access to regulated healthcare markets.