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February 2025

New Swissmedic Guidance on Medical Device Maintenance – 2025 Edition Now Available

Regulatory Updates /

Swissmedic has just released the 2025 edition of the Swiss Good Practice for the Maintenance of Medical Devices (GPI V2). This updated guidance provides essential recommendations to ensure compliance, patient safety, and the optimal performance of medical devices throughout their lifecycle. 🔍 Key updates in the 2025 edition: ✔️ Revised maintenance standards aligned with the latest regulatory requirements […]

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AI and Data Security: Methods for Detecting Data Leaks in the MedTech Sector

Knowledge & Resources /

With our last LinkedIn article, “Balancing Transparency and Intellectual Property: Obligations of Data Processing Service Providers in the Medical Device Industry”, we were asked about a reliable method to prove data leakage through AI. This is a critical issue, particularly in industries such as healthcare and MedTech, where data security is strictly regulated. Our article focuses

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New MHRA Guidance on Digital Mental Health Technologies (DMHT)

Regulatory Updates /

The MHRA has published new guidance on device characterisation, regulatory qualification, and classification: 👉 Digital Mental Health Technology – Regulation and Evaluation for Safe & Effective Products This guidance is applicable to Digital Mental Health Technology (DMHT) products placed on the UK market, covering Great Britain (England, Wales, Scotland) and Northern Ireland. It explains the

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MHRA Update: Nanomedicine Decision Tree Released

Regulatory Updates /

On 5 February, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a Nanomedicine Decision Tree—a structured tool designed to guide manufacturers, developers, and regulatory professionals in determining the appropriate regulatory pathway for nanomedicines. This decision tree aims to support researchers and developers in navigating the application of various guidelines from the International Council

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