A medical device can be as simple as a bedpan or as complex as an individually designed sensor that remotely monitors the functionality of organs in breathing individuals. All medical devices, however, have one thing in common: they all strive to meet the highest level of internationally recognized quality standards when they are created by … Continue reading ISO 13485 Prerequisites Top Medical Device Quality Management Standard: FAQ
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What Is ISO 13485 Certification
ISO 13485 stands for Medical devices -- Quality management systems Requirements for regulative purposes is an International Organization for Standardization. ISO 13485 was first announced in 1996 and the current standard was published on 1 March 2016. The latest version has a higher accent on risk management and risk-based decision making, as well as differences … Continue reading What Is ISO 13485 Certification