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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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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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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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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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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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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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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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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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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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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