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    • Regulatory Consulting Services
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News

risk management training medical device

ISO 14971:2019 Risk Management for Medical Devices

CoursesBy Anne Arndt8 February 2025Leave a comment

Date: 9 & 10 April 2025 | Time: 11:00 AM – 3:00 PM NZT (Two Half-Day Sessions) Cost: NZD 950 | Format: Online Master the fundamentals of ISO 14971:2019 and…

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qmsr

Top-Up Training: 21 CFR Part 820 – Preparing for QMSR

Courses, SeminarsBy Anne Arndt7 February 2025Leave a comment

Date: 22 & 23 April 2025 | Time: 1:00 PM – 5:00 PM NZT (Half-Day Sessions) | Price: NZD 800 | Place: Online via Zoom Prepare for the transition to the…

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Labelling australia

Medical Device Labelling in Australia: What Manufacturers and Sponsors Need to Know

Regulatory AffairsBy Anne Arndt5 February 2025Leave a comment

Medical device manufacturers and sponsors operating in Australia must ensure their products meet strict regulatory standards. The Therapeutic Goods Administration (TGA) has updated its guidance in 2024 to clarify how…

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regulatory strategy course medtech new zealand and australia

Regulatory Strategy – Accelerator Programme

accelerator, CoursesBy Anne Arndt3 February 2025Leave a comment

Start Date: 1 April 2025 | Cost: NZD 1,800 per month / NZD 5,400 Here’s your chance to fast-track your product’s market entry with Johner Institute New Zealand’s cutting-edge Regulatory…

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qms basics

Quality Management System (QMS) – Basics – Accelerator Programme

accelerator, CoursesBy Anne Arndt30 January 2025Leave a comment

Start Date: 12 March 2025 | Cost: NZD 1,800 per month / NZD 5,400 Embark on a 3-month journey with Johner Institute New Zealand to master the intricacies of ISO…

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C5 certificate germany thumbnail

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

Regulatory AffairsBy Anne 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

acceleratorBy Anne 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!

Regulatory AffairsBy Anne 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

Regulatory AffairsBy Anne 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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AI Act European Flag

The European AI Act and Its Impact on Medical Devices Worldwide

Regulatory AffairsBy 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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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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