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Ben Kemp

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MHRA Safety Roundup: May 2025

Note that MHRA have issued the below notice regarding Biotin Interference with Thyroid Function Tests (Immunoassays). FDA had previously issued guidance regarding this topic Testing for Biotin Interference in In Vitro Diagnostic Devices | FDA. Although MHRA have specifically highlighted the issue with TFT tests, manufacturers should consider Biotin interference with their Immunoassays more generally. MHRA have an ongoing consultation…
Ben Kemp
June 9, 2025
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveIndustry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA Consensus Standards

FDA have updated the consensus standards- as at 26/05/2025. For the degree of recognition click on the recognition information column - Recognized Consensus Standards: Medical Devices This includes many CLSI updates for IVDs including some software aspects. Below are just the IVD updates. 05/26/2025 InVitro Diagnostics 7-328 Partial CLSI M100 35th Edition Performance Standards for Antimicrobial Susceptibility Testing   05/26/2025…
Ben Kemp
June 9, 2025
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA Guidance – June 2025

These are the updates published since 07/01/2025 (when we last put updates on regulatory newsletter) up to and Including 29/05/2025. Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program | FDA Evaluation of Sex-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff | FDA Data Standards Catalog | FDA…
Ben Kemp
June 9, 2025
HighlightsHighlights Archive

Media Monitoring: 29th May – 4th June

How a dramatic decline in hepatitis C infections in England brings us close to elimination UKHSA’s latest data reveals a 56.7% decline in chronic hepatitis C virus (HCV) infections across England. With cases dropping from an estimated 129,400 in 2015 to 55,900 in 2023, significant strides have been made towards eliminating HCV in England.   UK is no better prepared:…
Ben Kemp
June 3, 2025
Funding OpportunitiesMembership NewsMembership News Archive

Latest NIHR Funding Opportunities

We would like to make members aware of the latest NIHR funding opportunities which have recently opened. Health Technology Assessment - Spinal muscular atrophy screening Closing date: 24 September 2025 at 1:00 pm NIHR's Health Technology Assessment (HTA) Programme is looking to fund research into spinal muscular atrophy screening. This is a 2-stage, commissioned funding opportunity. To apply for the first stage you…
Ben Kemp
June 3, 2025
Membership NewsMembership News Archive

Welcome to our new members: Fujifilm and Clinical Immunology Services (Uni. of Birmingham)!

We are delighted to welcome our two newest members to BIVDA: Fujifilm Healthcare UK and Clinical Immunology Services (University of Birmingham). Fujifilm Healthcare UK is a leading provider of innovative medical imaging systems and healthcare solutions. Their portfolio covers digital X-ray, mammography, ultrasound, CT, MRI, enterprise imaging solutions (including PACS, VNA, Clinical Workflow Management and 3D surgical planning tools), AI,…
Ben Kemp
June 3, 2025
Membership NewsMembership News Archive

The Gates Foundation: Innovative Diagnostic Devices for Priority Conditions Impacting LMICs

The Gates Foundation Diagnostics Team invites you to complete a Request for Information on Innovative Diagnostic Devices for Priority Conditions Impacting LMICs by June 15, 2025. The Diagnostics Team at the Gates Foundation focuses on developing affordable, scalable diagnostics and screening tools for tuberculosis, malaria, HIV, sexually transmitted infections, HPV, anaemia, pneumonia, Neglected Tropical Diseases and other infectious diseases, and…
Ben Kemp
June 3, 2025
Membership NewsMembership News Archive

Metrological Traceability for In Vitro Diagnostic Medical Devices Survey

Accurate, informative, and comparable biomarker measurements from commercial in vitro diagnostic (IVD) tests are essential for sound medical decision-making. In accordance with the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the metrological traceability of values assigned to calibrators and/or control materials must be ensured through appropriate reference measurement procedures (RMPs) and/or certified reference materials (CRMs) of higher metrological order. Despite…
Ben Kemp
June 3, 2025
Membership NewsMembership News Archive

Podcast: From Vision to Venture – How to give a Perfect Pitch to Investors

BIVDA member Remtec Talent Management have produced the latest episode of their podcast, 'From Vision to Venture', which may be of interest to members. In this 35-minute episode, host Nigel Job examines what a life sciences innovator seeking capital should do to maximise their opportunity in front of investors. He is joined by two experts in their field: Joey Mason…
Ben Kemp
June 3, 2025
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