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.
No matter what kind of medical device you are working on, there are some general requirements related to safety which will apply to your medical device, or the development process of that device. This article will introduce the general
The instructions for use is not only something which is referred to in many ways, such as user guide, operating manual or labelling. It is also a document which can be instrumental in achieving safety for a medical device.
The new Medical Device Regulation applies to all legal manufacturers of medical devices, as well as importers and distributors of medical devices that are to be sold on the EU market. The European Commission describes the new MDR as
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.
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