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Ben Kemp

QServe and TUV SUD – Navigate AI in MedTech: Live Regulatory Insights Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

QServe and TUV SUD – Navigate AI in MedTech: Live Regulatory Insights

We'd like to invite you to a live, practical webinar on Ensuring Quality in AI Driven Devices, hosted by Qserve experts and a guest speaker from Notified Body TÜV SÜD. We will unpack the regulatory expectations, explain what TÜV SÜD assesses during a submission review, and share examples from real-world cases, including those involving AI-supported clinical evaluation activities. Thursday, January 29,…
Ben Kemp
January 23, 2026
MedTech Europe update on EUDAMED progress MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

MedTech Europe update on EUDAMED progress

Mandatory use of the first four EUDAMED modules (Actor registration, UDI/Devices registration, Notified Bodies & Certificates, and Market Surveillance) starts as of 28 May 2026 EUDAMED PLG v3.22 released on 12 December: This release includes updates reflecting feedback from the VGL CA Board’s coordinated testing. According to the release notes, it is now possible to change the referenced device in…
Ben Kemp
January 23, 2026
The TGA releases compliance principles, reinforcing proactive and risk-based enforcement throughout 2026 and 2027 Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

The TGA releases compliance principles, reinforcing proactive and risk-based enforcement throughout 2026 and 2027

The TGA releases compliance principles, reinforcing proactive and risk-based enforcement throughout 2026 and 2027 The Therapeutic Goods Administration (TGA) has released its compliance principles for the next 2 years, setting out a refreshed approach to compliance and enforcement to protect public health. The TGA Compliance Principles 2026 and 2027 outlines our strategic approach to monitoring and enforcing regulatory compliance for…
Ben Kemp
January 23, 2026