This following would apply to members based in Northern Ireland conducting these tasks, or members distributors, performing these tasks in the EU: Article 16(4) Certification Scheme As part of BSI’s commitment to ensuring patient safety while supporting timely market access to global medical device technologies, we are pleased to inform you that we are expanding our Notified Body services to…
Ben KempOctober 1, 2024
UKHSA Conference 2025 Page summary: Save the date for the UKHSA Conference 2025. Hosted at Manchester Central on 25 to 26 March in partnership with the Faculty of Public Health (FPH). Change made: Updated ‘submit an abstract’ as the submission period has now closed. Time updated: 12:30pm, 25 September 2024
Ben KempOctober 1, 2024
This guidance provides recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralized elements in clinical trials. Decentralized elements allow trial-related activities to occur remotely at locations convenient for trial participants. Decentralized elements can include, among other things, telehealth visits with trial personnel, in-home visits with remote trial personnel, or visits with local health care providers. In…
Ben KempSeptember 25, 2024
Medical device timelines and penalties The EU Artificial Intelligence Act (AIA) was approved on May 21, 2024. The AIA establishes requirements for compliance with AI systems and general-purpose AI (GPAI) models made available or used on the EU market. Stay ahead in the ever-evolving landscape of medical device regulations with our latest updates: AIA regulatory update 1 Scope, classification, conformity…
Ben KempSeptember 25, 2024
Patients are rapidly adopting AI for everything from second opinions to self-diagnoses, appointment scheduling, and more. Health care organizations must act now to guide patients on using AI in order to minimize risk, boost their engagement and enhance the overall patient experience. Join us for our free virtual event on October 9th to hear experts in the field of AI…
Ben KempSeptember 25, 2024
Don't miss the last chance to register for Cardiac Marker Dialogues 2024: Cardiac Biomarkers in Real Time - experiences and opportunities. There's not long until the meeting - book your place now! Hosted by UK NEQAS Cardiac Markers, Cardiac Marker Dialogues: Cardiac Biomarkers in Real Time - experiences and opportunities will be held in Glasgow on Thursday 26 - Friday…
Ben KempSeptember 25, 2024
The CDC Import Permit Program (IPP) regulations provide that any noninfectious biological agent or biological substance that is being imported into the U.S. must be accompanied by an importer certification statement confirming that the material is not known to contain or suspected of containing an infectious biological agent or has been rendered noninfectious. See 42 CFR 71.54. To assist with…
Ben KempSeptember 25, 2024
CLSI EP47 provides guidance for planning, performing, evaluating, and documenting reagent carryover experiments and guidance for ensuring that no significant reagent carryover occurs. This document is intended for developers of in vitro diagnostic tests, regulatory organizations, and medical laboratories. Price: $180 for PDF; $200 for Print Access it here.
Ben KempSeptember 25, 2024
CLSI have published EP47 Evaluation of Reagent Carryover effects on test results 1st Ed: https://www.linkedin.com/posts/clsilabnews_ep47-standards-lablife-activity-7242219650338410496-1aG5?utm_source=share&utm_medium=member_android
Ben KempSeptember 25, 2024