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 Part 820.22, and expected under European regulations like MDR and IVDR, internal audits help organisations stay compliant, avoid costly errors, and continuously improve their processes.…
Dates: 23 July & 29 July 2025 | 17 Sept & 25 September 2025
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 on the regulatory requirements for medical software, including Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD). This workshop is designed…
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 Strategy Course. Designed for medtech professionals and newcomers looking to make their mark in the medical device arena, this three-month course is your golden ticket…
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 AI Act, albeit with last-minute changes to the final text of the law. This milestone in AI legislation is now official – and the AI…
The introduction of the Quality Management System Regulation (QMSR) by the US Food and Drug Administration (FDA) on 2 February 2024 marks a pivotal change, as it updates the Quality Management Systems requirements under 21 CFR part 820 to closely align with the ISO 13485:2016 standard. This change represents a major transition for medical device…