Implementing a medical device quality management system, or QMS, is a regulatory requirement for medical device manufacturers. In the medical device industry, there is a strong focus on the regulatory requirements and creating conforming procedures. But a QMS should also…
Welcome to a plain language guide on the practical aspects of Software as a Medical Device (SaMD). This guide will break down the regulatory terms and help you understand SaMD and the IEC 82304-1 standard. What’s exciting about SaMD? The solutions…
Risk management for medical devices refers to the process of ensuring that medical devices are safe. Performing risk management is a regulatory requirement in all major markets for medical devices. The go-to standard for risk management is the ISO 14971 –…
In the pharmaceutical industry, a leading Corrective and Preventive Action (CAPA) process is essential for ensuring product quality and regulatory compliance. This blog post shares a seven-step approach that outlines the key stages for effective CAPA management. Read on to…
The IEC 62304 standard includes requirements for managing the life cycle of medical device software, from design and development to manufacturing, distribution, and post-market surveillance. This illustrated guide was written by Wasif Ali Syed, This guide will: What is medical…
Handling Out of Specification (OOS) results effectively is a challenge. Despite rigorous processes and controls, OOS results can and do occur. Understanding what they are, why they matter, and how to manage them is essential for maintaining compliance and ensuring…
Good draw knew bred ham busy his hour. Ask agreed answer rather joy nature admire wisdom.
