System quality assurance assessment and review services

Tender description

The Medicines and Healthcare products Regulatory Agency is preparing to tender for a new Notified Body and ISO 13485 certificating body for one of its centre "National Institute for Biological Standards and Control (NIBSC)". NIBSC is a multi-disciplinary scientific establishment whose purpose is to safeguard and enhance public health by standardising and controlling biological substances used in medicines. One of its key roles is the production of reference materials including in vitro diagnostic devices (IVDs) and we are preparing to tender for a new Notified Body and ISO 13485:2016 certification body. We currently have 45 staff that are involved in the design and manufacture of 91 IVD products of which, 44 are currently Annex II List A and List B, and 47 are currently self-certified. The Medicines and Healthcare products Regulatory Agency is preparing to tender for a new Notified Body and ISO 13485 certificating body for one of its centre "National Institute for Biological Standards and Control (NIBSC)". NIBSC is a multi-disciplinary scientific establishment whose purpose is to safeguard and enhance public health by standardising and controlling biological substances used in medicines. One of its key roles is the production of reference materials including in vitro diagnostic devices (IVDs) and we are preparing to tender for a new Notified Body and ISO 13485:2016 certification body. We currently have 45 staff that are involved in the design and manufacture of 91 IVD products of which, 44 are currently Annex II List A and List B, and 47 are currently self-certified.