IEC 62304 Update: What’s Changing & Why It Matters
IEC 62304 is finally getting a much-needed update! The goal? To keep up with the fast-moving world of software, AI, and evolving regulatory frameworks and make it more relevant and better aligned with other industry guidelines. Proposed Key Changes: The updated standard will apply to: New Software Process Rigor Levels: Proposed to change from current […]
Regulatory Affairs in Change Management – Staying Compliant and Competitive
Change is inevitable, and this is especially true for the medical devices industry! Whether it’s through evolving regulations, technological advancements, or tweaks to product design, a solid strategy is needed for medical device manufacturers to avoid the many pitfalls that come with change. Regulatory affairs play a crucial role in managing changes effectively by ensuring […]
IEC 62366-12015 – Usability Testing for Medical Devices – Everything you need to know
Creating a usability file is a crucial part of the product development process for medical devices, including Software as a Medical Device (SaMD), in order to ensure user-centred design and safety. IEC 62366-1 is the international standard that outlines the process for applying usability testing to medical devices. It provides a structured approach to ensure […]
How to Create Effective Clinical Evaluation Reports for Medical Devices and SaMD
Overview of the Clinical Evaluation for Medical Devices CE Marking is the entry to selling medical devices in Europe, under the EU Medical Device Regulation (MDR) 2017/745. EU MDR indicates that manufacturers ‘shall plan, conduct and document a clinical evaluation’. The requirements for the clinical evaluation of medical devices are laid down in Article […]
ISO 13485 and CE Marking Audits – How to Succeed
If you’re a medical device manufacturer, passing ISO 13485 and CE Marking audits is a critical milestone. These audits are not just about compliance – they’re about demonstrating that your products are safe, effective and ready for market. Let’s walk through what to expect from these audits, how they’re connected and tips to prepare. ISO […]
What is the AI ACT? And what does it mean for medical device manufacturers?
It feels like in the past couple of years, everyone has been talking about AI! But is it about time the Regulations caught up with the ever evolving and advancing medical device technologies. The AI Act 2024/1689 is a legal Framework on Artificial Intelligence, which follows a risk-based approach, approved in May 2024. It provides […]
