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Ben Kemp

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UK AMR infections surpass pre-pandemic levels

National surveillance data published by the UK Health Security Agency has shown that antibiotic resistant infections in 2023 surpassed pre-pandemic levels. There were an estimated 66,730 serious antibiotic resistant infections in 2023, compared to 62,314 in 2019. The English Surveillance of Antibiotic Prescribing and Utilisation Report (ESPAUR) shows that the majority of antibiotic resistant bloodstream infections in the last 5 years (65%)…
Ben Kemp
November 19, 2024
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA consultation on Medical Devices Regulations for routes to market and IVDs

The MHRA last week opened their consultation on Medical Devices Regulations for routes to market and in vitro diagnostic devices. This relates to the proposed pre-market Statutory Instrument which is planned to be laid before parliament next year. The MHRA are seeking views as a number of changes have occurred since they previously consulted last year. Areas are: -     International…
Ben Kemp
November 19, 2024
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CLSI C34 | Sweat Testing: Specimen Collection and Quantitative Chloride Analysis

Newly Released Screening & Collection Guidance   CLSI C34 | Sweat Testing: Specimen Collection and Quantitative Chloride Analysis Date of Publication: 8 November 2024 Price: $180 for PDF CLSI C34 describes methods for all aspects of sweat testing, including collection and analysis, results evaluation and reporting, and quality control. You can purchase it here.
Ben Kemp
November 14, 2024
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Latest Blog: Creating a Circular Eco-System for Medical Devices: Single-Use vs Reuse

This is the latest blog in the Creating a Circular Eco-System for Medical Device series that aims to highlight different aspects and challenges of a circular economy in the healthcare and medical device industries. It addresses the principle of reuse and the struggle with choosing single-use or reusable devices, focusing on four (of many) areas that a manufacturer must consider.…
Ben Kemp
November 14, 2024
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