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Regulatory Affairs

Labelling australia

Medical Device Labelling in Australia: What Manufacturers and Sponsors Need to Know

By Anne Arndt5 February 2025Leave a comment

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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C5 certificate germany thumbnail

Attention Cloud Providers: New C5 Requirements for Healthcare in Germany!

By Anne Arndt9 October 2024Leave a comment

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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ARTG Australia Inclusion Checklist

ARTG Inclusion Checklist: Leverage Overseas Certification and Streamline Your TGA Approval!

By Anne Arndt5 September 2024Leave a comment

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…

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qsr qmsr iso

Download Our Comprehensive Comparison of QSR, QMSR and ISO 13485 Requirements

By Anne Arndt9 August 2024Leave a comment

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,…

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AI Act European Flag

The European AI Act and Its Impact on Medical Devices Worldwide

By Dr. Anja Segschneider20 March 2024Leave a comment

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…

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FDA Quality Management System Regulation (QMSR)

New FDA Quality Management System Regulation (QMSR): Why Medical Device Manufacturers Need to Prepare Now

By Dr. Anja Segschneider29 February 2024Leave a comment

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…

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Therapeutic Products Act 2023 medtech

New Zealand’s Therapeutic Products Act 2023

By Anne Arndt5 November 2023Leave a comment

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…

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New FDA Cybersecurity Regulations

FDA’s New Cybersecurity Regulations for Medical Devices: Webinar Recap

By Anne Arndt11 September 2023Leave a comment

In today’s landscape of increasingly connected devices, the fusion of healthcare and technology offers transformative opportunities in patient care. However, this digital evolution also opens a Pandora’s box of cybersecurity…

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New Zealand Therapeutic Goods Bill

Revamping Regulation: The Imperative Shifts in New Zealand’s Therapeutic Products Bill

By Anne Arndt11 July 2023Leave a comment

The Therapeutic Products Bill, promising to revolutionize the regulatory landscape for therapeutic goods in New Zealand, has stirred intense discussions among experts and industry insiders. A recent event that vividly…

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Validation vs. Verification

Validation vs Verification: What’s the Difference in Medical Software?

By Anne Arndt1 June 2023Leave a comment

The difference between validation and verification, especially in the context of Software as a Medical Device (SaMD), can be quite nuanced and often confuses many. This is largely due to…

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