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.…
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…
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…
