Mike, you’re one of the driving forces behind AIMEDIQ. What inspired the idea? Having worked in Regulatory Affairs, I know that maintaining compliance with regulatory requirements is both time-consuming and prone to errors. My experience testing commercially available LLM tools was unsatisfactory due to the missing ability to verify the source of an LLM response […]
“You can’t just say the requirement came from the AI” Read More »
What is your area of expertise? I started in quality management at Medela AG in Baar 8 years ago. Document management, digital and physical archiving of process documents, labelling. I supported the creation and maintenance of technical documentation. I work in Quality Support at EUMEDIQ. Processing customer inquiries and organizing relevant documents are part of
Who is EUMEDIQ, anyway? This time: Gabi Read More »
This month, the MDCG, together with the Joint Artificial Intelligence Board, published a guidance document on how to handle AI-enabled medical devices under the forthcoming AI Act (AIA) in parallel with existing requirements under the MDR/IVDR. The document introduces the term Medical Device AI systems (MDAIs) and provides a structured overview of how the two
New MDCG Guidance: AI Act and MDR/IVDR – What MedTech manufacturers need to know Read More »
Lisa, we’ve got something new with ISO 11137-1. Let’s dive straight in. What are the main updates in the 2025 revision compared to the previous version? The 2025 version introduces several changes but to me the most important one seems to be the updated normative references. ISO 11137-1 now references ISO 13004 and ISO/ASTM 52628,
Radiation sterilisation, simplified: Lisa explains the key updates in ISO 11137-1 Read More »
Last month, we launched our newest service offering: Computerised System Validation (CSV) – a practical, scalable solution designed to help MedTech companies remain audit-ready and compliant in an increasingly digital and regulated environment. But validation doesn’t stop at go-live. In fact, it’s where the real journey begins. As systems evolve and businesses adapt, so too
Ongoing Validation: Why Compliance Doesn’t Stop After Go-Live Read More »
What is your area of expertise? I am the marketing person at EUMEDIQ and am responsible for ensuring that we reach medical device manufacturers where they need pragmatic solutions and find a partner who keeps an eye on every detail in the highly regulated MedTech environment. For example? For instance, start-ups. Small, innovative companies with
Who is EUMEDIQ, anyway? This time: Bea! Read More »
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
New Swissmedic Guidance on Medical Device Maintenance – 2025 Edition Now Available Read More »
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
AI and Data Security: Methods for Detecting Data Leaks in the MedTech Sector Read More »
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
New MHRA Guidance on Digital Mental Health Technologies (DMHT) Read More »
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
MHRA Update: Nanomedicine Decision Tree Released Read More »