ISO 62304 Training Guide Introduction to ISO 62304 ISO 62304 is the international standard that defines the life cycle requirements for medical device software. It provides a structured approach to software development, maintenance, risk management, and problem resolution for medical...
In the rapidly advancing world of medical technology, software plays a critical role in ensuring the safety and performance of medical devices. ISO 62304 is the internationally recognized standard that governs the software life cycle processes for medical device software....
Benefits of Implementing IMS in Power Plants The benefits of implementing IMS in power plants—specifically by integrating ISO 9001, ISO 14001, and ISO 45001—are extensive and critical in today’s energy sector. An Integrated Management System (IMS) merges quality, environmental, and...
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...
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...
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