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 […]
ISO 13485 Secrets: Strengthen Your Quality Management System For Success
In the fast-moving world of medical devices, ensuring safety and effectiveness is paramount. Regulatory bodies worldwide enforce stringent quality management system (QMS) requirements to guarantee consistency, safety, and reliability. These requirements vary depending on the target market and the governing regulations. ISO 13485:2016 is the globally recognised harmonised standard for QMS in the medical device […]
Medical Device Compliance Demystified: 5 Critical Stages Of Regulatory Intelligence You Need To Know
Mastering Medical Device Compliance: The 5 Crucial Stages of Regulatory Intelligence In the rapidly evolving world of medical devices, staying compliant with regulatory intelligence can feel like a monumental task. The constant updates, changes, and complex requirements can be overwhelming. But don’t worry, we’re here to help. By following five fundamental stages, you can proactively […]