This guide will break down the regulatory terms and help you understand SaMD and the IEC 82304-1 standard. It discusses AI, ML, continuous integration and continuous deployment (CI/CD) when developing software as a medical device (SaMD).
This illustrated guide provides a useful overview of IEC 62304, clarifies terminology used in the standard, and addresses common misconceptions in medical device software development.
This article explores the significance of clinical investigations in assessing the safety and effectiveness of software as medical devices (SaMD) and how they contribute to advancing patient care and medical innovation.
Learn more about the mandatory General Safety and Performance Requirements or GSPR needed when placing a medical device on the EU market. These GSPR can be found in Annex I of the Medical Device Regulation.
Implementing a medical device quality management system, or QMS, is a regulatory requirement. In the medical device industry, there is a strong focus on the regulatory requirements but a QMS should also make the organisation efficient and result in products that have high quality.
The requirement of having a policy for establishing criteria for risk acceptability was added in the ISO 14971:2019 version of the standard was because the concept was often misunderstood in the previous 2007 version of the standard.
Among other things, this illustrated guide provides a useful overview of quality management for medical devices and ISO 13485, clarifies terminology used in the ISO 13485 standard that is defined elsewhere, and addresses common misconceptions.
As the final part of this series, this article focuses on categorising risks based on the different life-cycle phases of a medical device in order to efficiently address them to avoid harm. Not all medical device manufacturers segment their documentation into three distinct documents but risk association with life-cycle phases is common in the industry.
Part 2 of this series of three articles investigates the dangers of dividing risk management documentation in general or according to Team NB’s recommendation. By using a heart-lung machine as an example, this article will present a comprehensive approach to risk control measures in medical device risk management.
Take a look at our online Risk Management course on ISO 14971:2019 and online Design Control for Medical Devices course.
These courses are taken by both competent authorities, notified bodies and medical device manufacturers and distributors.