B. Braun Sterilog Ltd are a registered medical device decontamination service provider, authorised by the UK regulatory body, the Medicines and Healthcare Products Regulatory Agency (MHRA), to process reusable medical devices from our facilities in compliance with the Medical Device Directive MDD 93/42/EEC (rev 2007/47/EC). Our Notified Body is the British Standards Institute (BSI).
B. Braun Sterilog Ltd takes a robust approach to compliance measures ensuring documentation, procedures, plant and equipment, staff protocols and training policies are subject to regular internal and external audit in accordance with the Quality Assurance Standard ISO 13485.
Our Quality Management System (QMS) controls all aspects of our process management and sets out our commitment to quality at the highest level; our supporting procedures and work instructions are used to deliver staff training to ensure those commitments are realised at every level of the organisation.