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 […]

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

In her previous article, Lisa Kamber described how small companies in the MedTech environment particularly struggle with regulatory and other typical hurdles before they can even bring their innovative products to market. For small MedTech companies aiming to navigate the complex regulatory landscape in Europe, the following recommendations can be valuable: Understand regulatory pathways early

In recent years, various data protection regulations and laws have been published globally, many mirroring aspects of the European GDPR. A key principle in these regulations is the transparency of data processing. This principle mandates that data controllers provide individuals with insights into the reasons, methods, entities, and processes involved in data processing, allowing them

Small MedTech companies in Europe face a multifaceted array of challenges, including navigating complex regulatory landscapes, securing funding, protecting intellectual property, and managing manufacturing processes. These companies also need to stay updated with rapid technological advancements, ensure compliance with regulations, and achieve clinical adoption and market access amidst stiff competition. These obstacles highlight the intricate

In the previous article about ISO 13131, our Data Privacy expert Roland Schnitter explored the structure and content of this standard. He also examined how ISO 13131 interfaces with quality management system standards like ISO 13485 and ISO 27001 and discussed the potential for effort reduction through the elimination of redundancies. So, how does ISO

ISO standard 13131 provides a framework for managing telehealth services as part of the medical device environment. It combines the baselines of standards for risk management and medical devices with regulatory requirements derived from the AI (Artificial Intelligence) Act, Data Act and GDPR. Laws / regulations / guidelines: ISO 13131:2021 ISO 13485:2016 ISO 14971:2019 ISO