If you are certified according to DIN EN ISO 13485, or if that is your goal, you have probably already come across tool validation. Perhaps this article can help you and shed some light on the subject. Why do you need ...
01/10/2022
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 ...
05/07/2021
Do you have your measuring instruments calibrated? Do you know what to look out for? As part of our quality management system according to ISO 13485, we also have a process for measuring and testing equipment and calibrate some of our important measuring instruments. We develop new circuits. ...
01/29/2019
SW metrics from a QMS perspective Why should software quality metrics be used in the product lifecycle? A software metric maps a software unit into a numerical value. The numerical value represents a measure of the internal quality of software. Software code metrics are ...
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