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.
This article provides an in-depth explanation of EUDAMED logins. You may want to know how to complete all the steps to register as an actor within the database, or how to search for the information you need.
The EUDAMED database enhances traceability, cooperation, and transparency regarding medical devices in the EU. The database is split up in six modules with specific purposes. This article provides an overview of the areas that these modules covers.
During the pandemic, ISO 13485:2016 is available for free. You cannot download it as a pdf, but the full text is available online. Do not miss the list of other free standards available at this time.
This article focuses on the purpose and scope of essential SOPs (Standard operating procedures) and controlling documents in a QMS. It also covers how and why you should write a thought-through purpose for your SOP or controlling document and how this impacts efficiency.
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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