IEC 62304 Update: Powerful Changes You Need To Know And Why They Matter
Introduction to IEC 62304 IEC 62304 is a key international standard for the lifecycle processes of medical device software. It outlines the necessary processes for software development, maintenance, and risk management. Originally published in 2006, IEC 62304 has provided guidance to manufacturers, ensuring that software used in medical devices is safe, effective, and in compliance […]
This Is What You Need To Know About Regulatory Affairs In Change Management: Unlock Compliance And Dominate The Market
Introduction to Regulatory Affairs and Change Management Change is a constant in the medical device industry. From evolving regulations to technological advancements and shifts in product design, manufacturers must stay agile to thrive. Regulatory affairs play a critical role in managing these changes to ensure compliance with global standards, maintain product quality, and continue meeting […]
IEC 62366-12015 – Usability Testing for Medical Devices: What You Need To Know To Stay Compliant
Creating a usability file is essential in the product development process for medical devices, including Software as a Medical Device (SaMD), to ensure user-centred design and safety. IEC 62366-1 is the global standard outlining the process for usability testing in medical devices. This comprehensive guide will explore the critical steps involved in creating a usability […]
How to Create Effective Clinical Evaluation Reports for Medical Devices and SaMD That Will Empower Your Business!
Overview of the Clinical Evaluation for Medical Devices CE Marking is essential for selling medical devices in Europe under the EU Medical Device Regulation (MDR) 2017/745. As outlined in Article 61 and Annex XIV of the EU MDR, manufacturers must plan, conduct, and document clinical evaluation reports. This evaluation ensures that medical devices and […]
How To Succeed In ISO 13485 & CE Marking Audits: Your Step-by-Step Guide
Passing ISO 13485 and CE Marking audits is a critical milestone for medical device manufacturers. These audits are not just about meeting compliance requirements, they’re about proving that your products are safe, effective, and ready for the market. In this guide, we’ll walk you through what to expect from these audits, how they’re connected, and […]
The AI Act & Medical Devices: What You Need To Know Now
The AI Act & Medical Devices: What You Need to Know Now Artificial Intelligence (AI) has been a hot topic in recent years, revolutionising industries worldwide. But as AI advances, so must the regulations that govern it. The AI Act (Regulation 2024/1689) introduces a structured legal framework to ensure AI-driven technologies, including medical devices, are […]