The healthcare industry is facing a cybersecurity crisis like no other. In 2023, cybercriminals targeted healthcare with over 200 breaches, compromising 89 million patient records. By the first half of 2024, this wave of attacks surged by 9.3%, affecting 45.5 million more records. Ransomware,...
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...
Policy for establishing criteria for risk acceptability The requirement on having a policy for establishing criteria for risk acceptability was added to the ISO 14971:2019 version of the standard. The requirement is particularly important to meet MDR and IVDR requirements...
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 –...
Process validation is a crucial aspect when manufacturing medical devices, especially where the quality and safety of the final product cannot be fully verified without destructive testing. Understanding when and how to perform process validation is essential for maintaining both compliance and...
Clinical investigations for medical devices Clinical trials using medical devices are called clinical investigations, and the purpose of a clinical investigation is to answer important scientific questions. It must follow strict scientific standards (such as the ISO 14155 standard) which...
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 first thing one needs when working with quality management, as with numerous other areas within and outside the medical device industry, is their own copy of the standard. ISO 13485:2016 is the Medical devices – Quality management systems standard and it...
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...
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