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 […]
Understanding FDA 510(k) vs PMA: Navigating the Medical Device Approval Process
The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and effectiveness of medical devices before they reach the market. Two primary pathways for regulatory approval are the 510(k) premarket notification and the Premarket Approval (PMA) processes. Each pathway has its own requirements, benefits, and challenges. Understanding these can help […]
A guide to writing clinical evaluations in the EU MDR
Where should I start? See a brief summary below for tips on how to perform a successful clinical evaluation What is a clinical evaluation? Clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device in order to verify its clinical safety and performance. Clinical evaluation is an ongoing process conducted […]
7 things a performance evaluation must consist of
Under the IVDR Regulation (EU) 2017/746 (IVDR), all IVDs must undergo a Performance Evaluation before being placed on the market. The Performance Evaluation is an important aspect of the IVDR, as it ensures that IVDs are safe, accurate, and effective for their intended use. The requirements on carrying out a performance evaluation plan and report […]
