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Medical technology

Medical technology is about products, technologies and applications used in the diagnosis, treatment and support of diseases and disorders. Innovative technologies are rapidly being developed to improve care. Increasingly, medical technology determines the quality of care.


Field safety notices

Recent field safety notices (FSN's) from medical device manufacturers:

Field Safety Notice: Abbott Vascular - NC Trek_Traveler_Tenku RX Coronaire dilatatiekatheter

22-03-2017

Bij producten van de geïdentificeerde lotnummers kan de beschermhuls mogelijk moeilijk verwijderd worden, wat kan leiden tot problemen bij het opvullen of legen van de...

Field Safety Notice: Medtronic - DBS Lead Kit for Deep Brain Stimulation

20-03-2017

Medtronic heeft drie (3) klachten ontvangen van artsen, waarin werd aangegeven dat de DBS dieptestop niet doeltreffend aan de geleidingsdraad vast zat.

More field safey notices

News

Recent developments on the field of supervision of medical technology:

Manufacturers of silicone breast implants must improve their technical files 
09-06-2016
Laboratory investigation on the breast implants did not identify anomalies that may compromise health of patients. However, the technical files of the implants, which...

Investigation into possible problems with hypodermic needles reveals negligible risk
07-05-2015
Hypodermic needles produced by Terumo and other manufacturers pose negligible health risks. There is no reason not to use these needles. Nevertheless, Terumo should...

More news     


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Requirements for labelling, instructions and language

Requirements for labelling, instructions and language

Each medical device must be accompanied by a clear label, instructions for use and, where applicable, a display.

Conducting clinical research with a medical device?

Conducting clinical research with a medical device?

Read more about how to notify clinical research and report Serious Adverse Events to the Inspectorate.