Medical device compliance is rarely the problem in theory. The challenge is making ISO 13485 and regulatory requirements work in real companies, with real products, limited time, and competing priorities. That’s exactly why we’ve launched Quality and Regulatory Compliance for Medical Device Manufacturers, a tailored, one-on-one training service designed to build practical, audit-ready capability inside your…
Are you ready for the QMSR? FDA’s new Quality Management System Regulation (QMSR) lands in February 2026 and it will raise the bar by aligning more closely with ISO 13485. If your system has grown up around 21 CFR 820, the big question is simple: have you already covered the key differences — or are there gaps hiding…
We’re excited to be part of Innovate Western Sydney 2025 — a one-day event that brings together health innovators, tech leaders, founders, and researchers to explore what’s next for Western Sydney’s thriving innovation ecosystem. Taking place on 25 November at the Westmead Innovation Centre, the event features panels, startup pitches, breakout tours, and plenty of chances to connect — including…
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 the labelling requirements should be applied in practice. For businesses navigating the complexities of compliance, understanding these updates is essential to avoid regulatory pitfalls and…
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…
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…
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…
In a recent and notable development, the New Zealand government has repealed the Therapeutic Products Act 2023. This Act, which received Royal Assent on July 26, 2023, was originally intended to transform the regulatory framework for medical devices, medicines and natural health products in New Zealand. However, its repeal means a return to the older…
Are you prepared for the crucial role of Person Responsible for Regulatory Compliance (PRRC) as required under EU’s MDR (2017/745) and IVDR (2017/746)? Is your organization in compliance with Article 15? The understanding and implementation of these regulatory requirements is of paramount importance for every manufacturer of medical devices, regardless of their location globally. Key…