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Ben Kemp

Membership NewsMembership News ArchiveNear Patient Testing Working PartyNear Patient Testing Working Party Archive

Near Patient Testing Working Party – call for a Vice Chair

The NPT WP wants to appoint a vice chair to help set the agendas and topics for this member group. It is an exciting opportunity to help shape the future in POC and near patient testing and the activity in the NHS is substantial with dealing with the backlog, if you are interested in hearing more about this position, please…
Ben Kemp
February 10, 2023
Infectious Diseases Working PartyInfectious Diseases Working Party Archive

Infectious Disease Working Party, 2 February 2023

BIVDA held the infectious Disease working party meeting online last week. It was scheduled to be held in person but due to strikes, the meeting was moved online. Doris-Ann covered the innovation Service and the signposting for companies for new products and innovations for the NHS. The group were very keen to understand the pathways and BIVDA will be looking…
Ben Kemp
February 10, 2023
Membership NewsMembership News Archive

Medical Technology Strategy released

The UK’s inaugural medical technology (medtech) strategy has been released. It sets out how the health and social care system can reliably access safe, effective, and innovative medical technologies. The strategy builds on and supports the Life Sciences Vision to help secure the position of the UK as a global science superpower. The strategic priorities have been developed in conjunction with…
Ben Kemp
February 3, 2023
Membership NewsMembership News Archive

Strike action to affect goods entering the UK on 1 February

The Public and Commercial Services (PCS) union has announced Civil Service industrial action that will impact Border Force operations. The proposed strike action on February 1 2023 will impact international arrivals at all UK air and maritime ports as well as those travelling to the UK from UK border controls in Calais, Dunkirk and Coquelles in Northern France. Please see…
Ben Kemp
January 27, 2023
ConsultationsConsultations Archive

BS EN 556-2 EN 556-2 Sterilization of medical devices. Requirements for medical devices to be designated ”STERILE”. Part 2: requirements for aseptically processed medical devices

This document specifies the requirements for an aseptically processed medical device to be designated 'STERILE'. Please comment by 14 March 2023. To access the full document, click here. NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is permissible when a validated manufacturing and sterilization process has been applied. Requirements…
Ben Kemp
January 27, 2023
ConsultationsConsultations Archive

BS EN 556-1 EN 556-1 Sterilization of medical devices. Requirements for medical devices to be designated “STERILE”. Part 1: Requirements for terminally sterilized medical devices

This document specifies the requirements for a terminally sterilized medical device to be designated ‘STERILE’. Part 2 of this European standard specifies the requirements for an aseptically processed medical device to be designated “STERILE”. Comments can be submitted until 14 March 2023. For the full document, please click here. NOTE For the purpose of the EU Directive(s) for medical devices (see…
Ben Kemp
January 27, 2023
ConsultationsConsultations Archive

ISO/NP TS 20510 Guidelines to use synthetic biological reference materials for nanoscale imaging by electron microscopy for life sciences and clinical diagnostics

This document provides an overview of measurement procedures for biological sample analysis using electron microscopy. This is exemplified by synthetic nanoscale biological materials that have undergone a series of inter-laboratory comparisons and is offered as the first metrologically traceable biological reference material for the characterisation of biological and patient biopsy specimen using electron microscopy. An emphasis is also made on…
Ben Kemp
January 27, 2023
Membership NewsMembership News Archive

How can the NHS Innovation Service help IVD companies navigate the UK landscape to get new tests into clinical use?

There is a lot of support for life science companies available in the UK, including those with IVD products. However the support available is not always obvious, and historically it has been hard to navigate. The Accelerated Access Collaborative, part of NHS England, has recognised this and has set up a one stop shop called the NHS Innovation Service (Welcome…
Ben Kemp
January 27, 2023
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