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      • And more…
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November 2023


IT security for legacy devices

By Christian RosenzweigNovember 28, 2023Leave a comment

Understandably, laws and standards also require IT security for legacy devices. However, the way in which these requirements are formulated often leads to confusion. For example, legislators and standard committees have been unable to agree on common definitions. One definition refers to the IT security of legacy devices, another to the IT security of old…

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What manufacturers need to know about legacy devices

By Prof. Dr. Christian JohnerNovember 27, 2023Leave a comment

Legislators are continually changing the regulatory framework for medical devices, as we have seen in Europe with EU Regulation 2017/745 (MDR) and EU Regulation 2017/746 (IVDR). This then raises the question of how to deal with legacy devices. These are the medical devices that manufacturers have legally placed on the market under the old directives…

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Placing on the market: Definition and regulatory requirements

By Luca SalvatoreNovember 23, 20232 Comments

The EU regulations place high requirements on the so-called placing on the market of medical devices. Find out in this article what these regulations mean by placing on the market, what misunderstandings and contradictions you must be aware of, and what requirements manufacturers and devices must meet.

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Digitalization of the production

By Prof. Dr. Christian JohnerNovember 21, 2023Leave a comment

The digitalization of the production is an essential part of the digital transformation of manufacturing companies. However, not all companies benefit to the same extent from digitalization. This article describes,

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Developing a regulatory strategy: 6 good reasons 

By Luca SalvatoreNovember 14, 2023Leave a comment

Defining the regulatory strategy is one of the central tasks of the regulatory affairs departments at medical device manufacturers.  Why is a good regulatory strategy so important? What do regulatory affairs experts need to do? This article provides the answers. 

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Risk management plan: The most important advantages

By Christian RosenzweigNovember 7, 2023Leave a comment

The risk management plan is one of the most important documents in technical documentation. Accordingly, authorities and notified bodies examine this plan intensively. However, it is not only from a regulatory perspective that medical device manufacturers benefit from a precise risk management plan. This article

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