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Ben Kemp

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
Membership NewsMembership News Archive

DHSC set out their areas of research interest (ARIs)

This week, the Department of Health and Social Care have released their three areas of research interest (ARIs). These have been developed through wide consultation with policy teams across DHSC, NHS England and other stakeholders, and they have been approved by ministers. ARIs highlight to the patient, academic, clinical and life sciences community the areas where the Government seeks to…
Ben Kemp
January 27, 2023
Membership NewsMembership News Archive

BIVDA’s Head of Reg Affairs to speak at MedTech Conference – sign-up now!

Ashleigh Batchen, BIVDA’s Head of Regulatory Affairs is to speak at Element’s MedTech Conference in March alongside other esteemed guests, such as Professor Michael Lewis, Life Science and Innovation, University of Birmingham and Joint Director, NIHR and Lewis Oakley, Innovation Lead - Heath Technologies, Innovate UK. Element's MedTech Conference seeks to challenge the existing regulatory structures and discuss how medical…
Ben Kemp
January 27, 2023
Membership NewsMembership News Archive

Spotlight on Sustainability – Webinars and Training

As part of a new series we are highlighting BIVDA’s Sustainability Hub – a valuable free resource for BIVDA members. This week we’re covering…   Webinars and Training Recordings of previous webinars and training session presentations on sustainability are available on the Sustainability Hub. There are plenty to choose from including: • Tender Requirements including Net Zero and Social Value • Modern…
Ben Kemp
January 27, 2023
Membership NewsMembership News Archive

MedTech Europe Sustainability and Environment employment opportunities

MedTech Europe are recruiting a Sustainability and Environment Director and have secondment opportunities in the Sustainability & Environment area. Please see the postings below:   Open Recruitment: New ‘Sustainability and Environment’ Director Position   In light of the ever-growing importance of Sustainability to our industry, we are seeking a Director to lead our work in this domain going forward. This…
Ben Kemp
January 27, 2023
HighlightsHighlights Archive

Government to publish Major Conditions Strategy

This week, Health and Social Care Secretary, Steve Barclay, announced the Government's intention to publish a Major Conditions Strategy. He stated that this work held added importance as more of us are living with multiple major conditions which therefore presents a major opportunity to improve the lives of millions of people. Mr Barclay declared that the Strategy would set out…
Ben Kemp
January 27, 2023
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