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2025


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

By Anne Arndt16 June 2025Leave a comment

Discover how to successfully bring a medical device to market in this comprehensive 2-day introductory course. Two separate 2-day workshops are on offer for the second half of 2025. Dates: 23…

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internal auditor

The Internal Auditor: A Key Role in Quality Management

By Anne Arndt24 April 2025Leave a comment

Internal audits are not just a regulatory formality, they are a cornerstone of any effective quality management system. Required by international standards such as ISO 13485 and FDA’s 21 CFR…

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regulatory strategy course medtech new zealand and australia

Regulatory Strategy – Accelerator Programme – September

By 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

By 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

By 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

By 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

By Anne Arndt8 February 2025Leave a comment

Date: Two consecutive days, to be advised | Time: 11:00 AM – 3:00 PM NZT (Two Half-Day Sessions) Cost: NZD 950 | Format: Online Master the fundamentals of ISO 14971:2019…

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Labelling australia

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

By 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

By 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 – March

By 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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