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2024

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Attention Cloud Providers: New C5 Requirements for Healthcare in Germany!

By Annett Arndt9 October 2024Leave a comment

As of 1 July 2024, new regulations are in effect for all manufacturers offering cloud services in Germany’s healthcare sector. Providers must now present a C5 certification and meet strict…

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NEW DATES: Medical Devices – An Introduction to Product and Company Development in a Regulated Environment

By Annett Arndt24 September 2024Leave a comment

Discover how to successfully bring a medical device to market in this comprehensive 2-day introductory course by the Johner Institute New Zealand on 20 and 28 November. Designed for those…

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ARTG Australia Inclusion Checklist

ARTG Inclusion Checklist: Leverage Overseas Certification and Streamline Your TGA Approval!

By Annett Arndt5 September 2024Leave a comment

If you plan to sell medical devices in Australia, obtaining approval from the Therapeutic Goods Administration (TGA) is a crucial step. However, if your product already has certification from a…

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qsr qmsr iso

Download Our Comprehensive Comparison of QSR, QMSR and ISO 13485 Requirements

By Annett Arndt9 August 2024Leave a comment

The introduction of the Quality Management System Regulation (QMSR) by the US Food and Drug Administration (FDA) signifies a pivotal shift for medical device manufacturers. As of February 2, 2024,…

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The European AI Act and Its Impact on Medical Devices Worldwide

By Dr. Anja Segschneider20 March 2024Leave a comment

It’s done. The European Artificial Intelligence Act (AI Act) has finally become a reality. After years of back-and-forth, the time came on 13 March 2024: The European Parliament approved the…

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FDA Quality Management System Regulation (QMSR)

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

By 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

By Annett Arndt30 January 2024Leave a comment

Date: 24 April | Time: 11 AM NZT | Venue: Online via Zoom Join our online info session on 24 April at 11 am NZT to explore how our 12-month…

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Regulatory Strategy Course

Online Info Event: Regulatory Strategy Course

By Annett Arndt30 January 2024Leave a comment

Date: 17 April | Time: 11 AM NZT | Venue: Online via Zoom Join our online info session on 17 April at 11 AM NZT to explore how our 3-month…

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

By Annett 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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