Request for Information - Regulatory and Quality Managed Service for UKHSA Covid

The UK Health Security Agency (UKHSA) is responsible for protecting every member of every community from the impact of infectious diseases, chemical, biological, radiological and nuclear incidents and other health threats. We provide intellectual, scientific and operational leadership at national and local level, as well as on the global stage, to make the nation's health secure.

The Diagnostics and Innovation team has a remit across the United Kingdom to provide Regulatory and Quality support for Covid-19 lateral Flow devices, PCR specimen collection and antiviral kits and related software devices. This is applicable where UKHSA is the legal manufacture of devices or has a significant role in procuring, developing and or distributing Covid-19 medical and IVD devices

The Diagnostics and Innovation unit requires an integrated managed service to meet the Regulatory (MDR 2002 SI618) and MHRA requirements for these devices until no longer required which is anticipated to be 31st March 2024.

Should you wish to respond to this Request for Information, please complete and return the response questionnaire via the messaging section on the following eTendering portal which is found at the following link: https://health-family-contract-search.secure.force.com/ProSpend__CS_ContractPage?SearchType=Projects&uid=a078d000000vng8AAA&searchStr=&sortStr=Recently+Published&page=1&filters=&County=