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 territorial requirements. Although these changes may have slipped under the radar for some, they are highly significant. It’s crucial for manufacturers interested in the EU…
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 involved in product development and sales, business owners, founders, and CEOs, this course offers an in-depth overview of implementing a quality management system (QMS) and…
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 comparable overseas regulator, you can leverage this to streamline the approval process in Australia. This approach can save you significant time, effort, and money. The…
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, the QMSR updates the FDA’s Quality Management System requirements under 21 CFR part 820 to align more closely with the ISO 13485:2016 standard. With the…
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…
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 12-month Quality Management System (QMS) course is specifically designed to accelerate your startup’s journey from concept to launch! Why Attend Our Information Event? Our online…
Date: 17 April 2024 | Time: 11 AM NZT | Venue: Online via Zoom Join our online info session on 17 April at 11 AM NZT to explore how our 3-month Regulatory Strategy course is specifically designed to provide in-depth insights into Regulatory Strategy, pivotal for your start-up’s advancement in the medical device sector. Why…
We are delighted to announce that Johner Institute New Zealand (JINZ) is featured on the cover of the latest issue of MedTech Outlook magazine and has been named by MedTech Outlook as a Top Medical Device Consulting Company in APAC for 2023. In the cover story, you can read about our journey since the founding…