Knowledge & Resources

Global market access is complicated enough without the added confusion of persistent myths. From misunderstood MDSAP requirements to overestimated CE marking reach, these assumptions can derail your expansion timeline and budget. Let’s set the record straight.   ❌The myth: CE mark = instant market access across all European countries ✅ The reality: Whilst the CE […]

Understanding the critical difference between AI assistance and Regulatory Intelligence   The question we have heard a lot since the webinar As regulatory consultants and Authorised Representative, we’re increasingly asked: “Why can’t we just use ChatGPT or other general AI tools for our regulatory questions? They’re free and seem to know about regulations.” It’s a

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

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,

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

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

Introduction: Revisiting the Role of Information Security in MedTech In our previous article “The Benefits of Integrating an Information Security Management System to Medical Device Manufacturers,” we discussed the impact of having an information security management system related to compliance with the US Health Insurance Portability Accountability Act (HIPAA). In this article, we will provide

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Radiation sterilisation is growing rapidly within medical technology due to its efficiency, reliability, and adaptability to sterilise a wide range of healthcare products. Unlike traditional methods like ethylene oxide (EO), which can leave residues, radiation sterilisation offers a clean, residue-free process suitable for delicate single-use devices, including syringes, implants, and surgical instruments. As the demand

Introduction Manufacturers of active medical devices requiring batteries might face challenges during design and development. This might be because they have not been aware of regulation (EU) 2023/1542 concerning batteries and waste batteries, amending Directive 2008/98/EC and Regulation (EU) 2019/1020 and repealing Directive 2006/66/EC. This article is about specific topics which needs to be taken