Prof. Dr. Christian Johner

Inhaber der Johner Institut GmbH


ISO 19011: Audit management for medical device manufacturers under the MDR

ISO 19011 is the international guideline for auditing management systems. Therefore, your notified body considers ISO 19011 state-of-the-art when it checks during your ISO 13485 certification audit whether you are conducting your internal and supplier audits effectively. Consequently, those responsible for quality management, in particular, should be familiar with and consider ISO 19011. This article…

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Accessibility

Accessibility refers to the design of products and services that can also be used by people with physical limitations. The term “products and services” encompasses both physical and digital products and services. This also includes medical devices (physical devices, apps, other standalone software). This article explains which accessibility requirements manufacturers of medical devices should be…

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7 tips for the successful digital transformation of medical device manufacturers

Companies need to master the digital transformation quickly and successfully. This also applies to medical device manufacturers because, after all, their future depends on it. Many companies make severe mistakes during this transformation (see section 4). This article provides managers with a quick overview of the possibilities of digital transformation and gives seven tips to make it…

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