How to create a medical device work breakdown structure
A work breakdown structure is a very useful tool for any project manager, yet many do not know what it is. This article provides an overview of how a medical device work breakdown is created. If you would like to know more about creating a work breakdown structure...
What the EU MDR PMS plan must include
To achieve the purpose of the manufacturer’s PMS system, the manufacturer must have a PMS plan. This is also stated in Article 84 of the MDR. But article 84 basically only references Annex III, which is the annex that describes the requirements on the technical...
Project management in the medical device industry
What is project management for product development of medical devices? And most importantly, why should you be working with project management in the medical device industry? In this article, you will find the basic principles and practices of project management with...
Reporting post-market surveillance activities
Post-market surveillance reporting requirements are different depending on the classification of the devices the PMS system is covering. This article provides an overview of PMS reporting according to medical device classification. PMS reporting for class I medical...
Post-market surveillance as a medical device requirement in the EU
Dealing with post-market surveillance, or PMS, is a very important part of having medical devices on the EU market. It is also one of the focus areas of the notified bodies. This makes it essential for all manufacturers and others working within the medical device...
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