Are you still planning, or are you already developing? There's a lot of discussion about why a software development plan is even necessary. Almost no one would think of starting a major project without a plan. Who builds a house without a plan? ...
10/02/2017
ISO 13485:2016 requires a risk-based assessment of your processes in the quality management system (QMS). Many companies ask themselves whether only production processes should be considered, or whether all processes should be considered. Furthermore, the question often arises, ...
04/09/2017
Over 10 years in medical technology. What have I learned here, and what recommendations can I offer? Goran Madzar approached me with this question and asked if I'd be interested in writing a guest blog. I'm happy to help. ...
12/05/2016
Mistakes are unavoidable – that sounds unpleasant, but it isn't necessarily so. With good error management, we create a conscious approach to dealing with errors: The particularly nasty ones are prevented, some can be intercepted, and non-critical ones can even be allowed. ...
08/30/2016
Technological progress is affecting almost every industry and generally succeeds in raising both quality and productivity to a new level. These technologies, which are being used in an increasing number of application areas, include ...
04/23/2016
Lately, there has been a growing amount of bad news regarding the intrusion of information technology (IT) into hospitals and medical devices. After servers, routers, and cars, an anesthesia machine was also hacked. And hospital staff have ...
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