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RADIANT CERSI Innovators Survey

The RADIANT CERSI has launched an innovators survey aimed at better understanding the regulatory challenges and support needs of digital health and AI innovators. The CERSI network is supported by MHRA and UKRI. RADIANT aims to bridge the gap between regulatory science and real-world innovation, creating a sustainable and inclusive ecosystem for SMEs and innovators in Digital Health and AI. RADIANT…
Ben Kemp
February 3, 2026
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2025: Global Wireless Regulatory Overview

Global Wireless Regulatory Updates and Trends 2025   Considering regulatory changes early can help simplify your wireless product’s design, testing and certification processes — keeping your launch timeline on track.   Watch our on-demand webinar to receive the latest compliance updates impacting market access for Bluetooth, Wi-Fi, Cellular and short-range devices in Africa, Europe, Latin America, North America, the Middle East and Asia.   What you’ll learn: Key…
Ben Kemp
January 23, 2026
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TGA Australia – Proposed amendments relating to transparency of disruptions to supply of medical devices

Dear members, please let me know via regulatory@bivda.org.uk any feedback to the TGA Australia - Proposed amendments relating to transparency of disruptions to supply of medical devices. Consultation closes 20th Feb 2026.   TGA want your feedback on the proposed changes to improve transparency about disruptions to the supply of medical devices.   Consultation: Improved sharing of information about medical…
Ben Kemp
January 15, 2026
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Build a Stronger Lab: Strengthen Your Molecular Testing Systems

CLSI MM19 provides comprehensive recommendations for molecular diagnostic testing, that cover strategic planning, regulatory requirements, implementation, quality management, and special considerations for subspecialties of molecular genetics including infectious diseases, oncology, malignant hematology, and pharmacogenetics.
Ben Kemp
December 5, 2025
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October is Cybersecurity Awareness Month, is your team AI-ready? 

BIVDA member Qserve is running EU AI act literacy training that may be of use to members. The EU AI Act requires AI literacy training for staff developing and deploying as well as those using AI. AI Literacy - Questions & Answers | Shaping Europe’s digital future
Ben Kemp
October 2, 2025
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QServe Australia UDI

Qserve perspective on the new Australian TGA UDI requirements. Increasingly relevant as Australia is one of the countries MHRA have identified from international recognition under the proposals for the Pre-Market SI. *Please note, the above post on TGA UDI requirements shows the timelines table for medical devices rather than the IVD table as below.   TGA UDI Timelines for IVDs…
Ben Kemp
August 28, 2025
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