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News

FDA Quality Management System Regulation (QMSR)

New FDA Quality Management System Regulation (QMSR): Why Medical Device Manufacturers Need to Prepare Now

Regulatory AffairsBy Dr. Anja Segschneider29 February 2024Leave a comment

The introduction of the Quality Management System Regulation (QMSR) by the US Food and Drug Administration (FDA) on 2 February 2024 marks a pivotal change, as it updates the Quality…

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qms course info event

Online Info Event: Quality Management System (QMS) Course

acceleratorBy Anne Arndt30 January 2024Leave a comment

Date: 24 April 2024 | Time: 11 AM NZT | Venue: Online via Zoom Join our online info session on 24 April at 11 am NZT to explore how our…

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Regulatory Strategy Course

Online Info Event: Regulatory Strategy Course

acceleratorBy Anne Arndt30 January 2024Leave a comment

Date: 17 April 2024 | Time: 11 AM NZT | Venue: Online via Zoom Join our online info session on 17 April at 11 AM NZT to explore how our…

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Johner Institute New Zealand named Top Medical Device Consulting Company in APAC for 2023

Johner Institute NewsBy Anne Arndt2 January 2024Leave a comment

We are delighted to announce that Johner Institute New Zealand (JINZ) is featured on the cover of the latest issue of MedTech Outlook magazine and has been named by MedTech…

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Therapeutic Products Act 2023 medtech

New Zealand’s Therapeutic Products Act 2023

Regulatory AffairsBy Anne Arndt5 November 2023Leave a comment

In a recent and notable development, the New Zealand government has repealed the Therapeutic Products Act 2023. This Act, which received Royal Assent on July 26, 2023, was originally intended…

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free webinar machine learning

Free Webinar on Machine Learning in Medical Devices (31 October)

WebinarsBy Catherine Kappelle28 September 2023Leave a comment

Join us for our upcoming free webinar on Machine Learning in Medical Devices on 31 October at 11am (NZT). Tyler Harmon, an experienced expert in deep learning and machine learning,…

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PRRC Person Responsible for Regulatory Compliance Seminar

Seminar PRRC – Person Responsible for Regulatory Compliance – Nov 23-24

SeminarsBy Anne Arndt21 September 2023Leave a comment

Are you prepared for the crucial role of Person Responsible for Regulatory Compliance (PRRC) as required under EU’s MDR (2017/745) and IVDR (2017/746)? Is your organization in compliance with Article…

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New FDA Cybersecurity Regulations

FDA’s New Cybersecurity Regulations for Medical Devices: Webinar Recap

Regulatory Affairs, WebinarsBy Anne Arndt11 September 2023Leave a comment

In today’s landscape of increasingly connected devices, the fusion of healthcare and technology offers transformative opportunities in patient care. However, this digital evolution also opens a Pandora’s box of cybersecurity…

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DevSecObs Webinar New Zealand

Shift Left on Security with Patient Zero – Free Cybersecurity Webinar 21 Sept

WebinarsBy Anne Arndt26 August 2023Leave a comment

Free Webinar: Shift Left on Security with Patient Zero 21 September 2023 via Zoom Presenters: Dan Dekel, David Capper & Joe Cooney Want to dive deep into the realm of cybersecurity?…

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Thursday, 3 August Workshop - Developing Medical Software according to IEC 62304

Workshop – Developing Medical Software according to IEC 62304 (3 August 2023)

WorkshopsBy Anne Arndt20 July 2023Leave a comment

Join us for an insightful workshop centered on the regulatory landscape of Software in Medical Device (SiMD) and Software as a Medical Device (SaMD) products. This event is jointly presented…

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Recent Posts

  • ISO 14971:2019 Risk Management for Medical Devices
  • Top-Up Training: 21 CFR Part 820 – Preparing for QMSR
  • Medical Device Labelling in Australia: What Manufacturers and Sponsors Need to Know
  • Regulatory Strategy – Accelerator Programme
  • Quality Management System (QMS) – Basics – Accelerator Programme
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