ISO 14971:2019 Risk Management for Medical Devices
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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Top-Up Training: 21 CFR Part 820 – Preparing for QMSR
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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Medical Device Labelling in Australia: What Manufacturers and Sponsors Need to Know
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 – Accelerator Programme
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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Quality Management System (QMS) – Basics – Accelerator Programme
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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Attention Cloud Providers: New C5 Requirements for Healthcare in Germany!
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
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 Inclusion Checklist: Leverage Overseas Certification and Streamline Your TGA Approval!
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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Download Our Comprehensive Comparison of QSR, QMSR and ISO 13485 Requirements
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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Online Info Event: Quality Management System (QMS) Course
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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