Category: Regulations

Ever wondered whether it was sufficient to use ISO 14971 instead of EN ISO 14971 for the European medical device market? This gives a quick breakdown of what the difference is, and why you need the EN ISO.

If you want to get your medical device to market in the U.S. you need to know its classification. To do this you need to:

One problem many quality management systems have, is being too rigid. If a procedure keeps ‘getting in the way’ maybe it is time for another approach.