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  • Services
    • Regulatory Consulting Services
    • SaMD Consulting Services
    • External PRRC
    • External QMR
    • In-Country Representation
    • Regulatory Monitoring
    • Micro Consulting
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News

regulatory strategy course medtech new zealand and australia

Regulatory Strategy – Accelerator Programme – September

accelerator, CoursesBy Anne Arndt25 March 2025Leave a comment

Start Date: 10 September 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 Strategy…

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qms basics

Quality Management System (QMS) – Basics – Accelerator Programme – August

accelerator, CoursesBy Anne Arndt25 March 2025Leave a comment

Start Date: 13 August 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 13485…

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qmsr

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

Courses, SeminarsBy Anne Arndt17 March 2025Leave a comment

Date: 15 & 16 July 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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Medical Software Regulatory Requirements

CoursesBy Anne Arndt6 March 2025Leave a comment

May 27, 9 AM – 3 PM NZST | Location: Callaghan Innovation, Auckland | Cost: $50 Johner Institute New Zealand, in collaboration with HealthTech Activator, is hosting an interactive workshop…

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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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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 – April

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…

Details
qms basics

Quality Management System (QMS) – Basics – Accelerator Programme – March

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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Recent Posts

  • Regulatory Strategy – Accelerator Programme – September
  • Quality Management System (QMS) – Basics – Accelerator Programme – August
  • Top-Up Training: 21 CFR Part 820 – Preparing for QMSR
  • Medical Software Regulatory Requirements
  • ISO 14971:2019 Risk Management for Medical Devices
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