Skip to main content
search
Category

Regulatory Affairs Newsletter Archive

Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

GOV.UK for: Department of Health and Social Care (WC 21 Oct)

Major crackdown on NHS waste Page summary: A new strategy is being published to radically cut the number of single-use medical devices in the health service. Change made: First published. Time updated: 12:15am, 16 October 2024 Life Sciences Vision Missions Page summary: Bringing together industry, academia, the third sector and the NHS to tackle healthcare challenges such as dementia, cancer,…
Ben Kemp
October 25, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

UKHSA Commercial and Partnerships Update

UKHSA Commercial and Partnerships Page summary: This guidance is designed to help UKHSA customers and partners to navigate engaging and working with us and to signpost upcoming events and opportunities. Change made: Information about UKHSA Conference 2025 added. Time updated: 10:16am, 17 October 2024
Ben Kemp
October 24, 2024
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

BSI Meet the Experts: In Vitro Diagnostics Regulation event – BIVDA Member 25% Discount

The BSI Meet the Experts: In Vitro Diagnostics Regulation event is taking place in Amsterdam on 27 November 2024. BIVDA members can get a 25% discount for the event. Make sure to use the code MTENLBIVDA at checkout. BIVDA members can register for the event here. This IVDR focussed event has been designed for regulatory professionals, specialists and consultants from…
Ben Kemp
October 22, 2024
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

NIHR Research Delivery Network Launched

The NIHR’s Research Delivery Network (RDN) launched on 1 October and marks a new chapter in the optimisation and delivery of health and care research in England. The RDN is a new organisation which has been set up to respond to the changing requirements of the health and care research system. Having taken over from the NIHR Clinical Research Network, the RDN…
Ben Kemp
October 16, 2024
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA Consensus Standards Update

FDA added three standards to the US Consensus Standards list in September for sterility.   Date of Entry Specialty Task Group Area Recognition Number Extent of Recognition Standards Developing Organization Standard Designation Number and Date Standard Title (click for recognition information) 09/09/2024 Sterility 14-460 Complete ISO 11140-1 Third edition 2014-11-01 Sterilization of health care products - Chemical indicators - Part…
Ben Kemp
October 16, 2024
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CLSI EP12

Evaluation of Qualitative, Binary Output Examination Performance, 3rd Edition This guideline includes descriptions of the types of qualitative, binary output examinations and procedures for evaluating their performance. This edition of the document was corrected in February 2024. Read the correction notices by accessing the link above, and learn more about our correction process here. Find out more here.
Ben Kemp
October 16, 2024
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Section 524B: Navigating Healthcare Cybersecurity Compliance

As the intersection of healthcare and cybersecurity continues to play a vital role in safeguarding patient data and the integrity of medical technologies, it is crucial for professionals in the healthcare sector to stay well-informed about legislative directives such as Section 524B. Are you a professional involved in medical software development and medical technology device manufacturing? Then this on-demand webinar…
Ben Kemp
October 16, 2024
Close Menu