If you are also active in medical technology, then you have probably already noticed that EN ISO 13485:2016 has a new annex: EN ISO 13485:2016+A11:2021 Since we are also an EN ISO 13485 certified development service provider, we have ...
12/06/2021
Systems engineering is concerned with the development of a high-quality overall product. Usability engineering, on the other hand, aims to enable the user to complete their tasks efficiently and effectively. Despite and because of their different focus, both principles should be ...
11/29/2021
1, 2 or 3 is not only the question in a well-known quiz show for children on public television, but also for companies that want to market a medical device in the EU. The MDR provides in Article ...
A product has been successfully approved and is on the market. Can cybersecurity activities now be discontinued? Of course, that's not possible. Cybersecurity risks arise continuously, and it's impossible to identify all vulnerabilities in advance. ...
07/19/2021
Medical devices have special requirements regarding usability. This is because incorrect use of medical devices can result in harm to patients or operators. To prevent this, IEC 62366-1 defines clear processes for the usability of medical devices. The standard applies ...
06/16/2021
References: When IEC 62304 or ISO 14971 is mentioned below, the following editions are meant: IEC 62304:2006 + A1:2015 and EN ISO 14971:2012 Problem: We are developing software/firmware that is a component of a medical device. The software (or the ...
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