Software for Quality Management Systems can roughly be divided into two categories. You can either purchase specialized regulatory software which has specific features for whatever regulated industry you’re in, or you can choose a generic software and attempt to re-purpose it as your regulatory software.

Question

We got audited by a competent authority - the LaGeSo in Berlin to be exact, as that’s where our company is located. Let me tell you how it went and what you need to know if you ever run the risk of getting audited by one (which is.. always, if you’re a medical device manufacturer in the EU). And, by the way, this probably is the first public report of a competent authority audit, ever. Cool!