This article covers the necessary regulations, standards, and guidelines related to process validation of medical devices in the US and the EU.
This illustrated guide will provide a useful overview of risk management and ISO 14971; and address common misconceptions within risk management.
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.
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.
This first article in a series of three will be discussing the dangers of dividing risk management documentation according to Team NB’s recommendation. When performing risk management according to ISO 14971, a lot of medical device companies split up risk management documentation into “design risk assessment”, “process risk assessment” and “use risk assessment”. Not only is this common practice, but it is also recommended by Team NB.
In June 2020, the IEC 62366-1 standard underwent some updates – Let us look at the eight most important changes in the AMD1:2020 in order of importance.
Usability engineering and risk management are connected in many ways, and all steps should be taken to ensure both safe and user-friendly medical devices for the end users.
This article explores the Covid-19 situation from a medical device risk management perspective and compares how the risks of Covid-19 would be addressed when applying ISO 14971 risk management compared to what governments have done.
This article aims to give tips and tricks so that medical device risk management work can be done more efficiently and effectively.
If your goal is to avoid being late and spending more money on a project than you have initially planned, keep reading. Project risk management is often a neglected area in project management when in reality, it is among
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.
Special launch offer: 349 299 EUR for the online plan & 449 349 EUR for the online lifetime plan.