Tools & Downloads
Quality Management System
To develop your medical device you have to make sure you document all steps in your process. If you want to bring it to market in the US and you need an FDA clearance it is even more of an issue: “not documented is not done”. So you need a quality management system (QMS) and a procedure for development. There are companies that can do this for you. You may find them at the tile. If you need or want to do it yourself, make sure you take care of documentation.
MDR IVDR (Dutch)
Assess through the flowchart whether you require a CE certificate for the distribution of your software and if seeking certification from a notified body is necessary
Medical Device Directive (in vitro diagnostic)
You are required to comply with the Medical Device Directive (MDD) in order to discover the necessary steps you should take. Similarly you can find the In Vitro Diagnostic devices and repealing Directive (IVDR).