Inhaber der Johner Institut GmbH
The digital transformation of notified bodies will transform the medical device ecosystem over the next few years. This article describes 1. Drivers of the digital transformation of notified bodies The period in which notified bodies, as an oligopoly, were allowed to pick and choose customers and determine prices and conditions is coming to an end.…
DetailsPractical guidance based on the experience of the Johner Institute, Oliver Hilgers, and Stefan Bolleininger The discussion about class I software continues to rage. This article provides guidance regarding the MDR rules for the classification of medical software. 1. Background a) Relevance of the issue Whether or not medical software counts as class I software is…
DetailsRegulators still publish laws and regulations as texts. Just as it has been for thousands of years. Regulation as Code represents a radical paradigm shift away from this practice. Is it possible to transform laws into algorithms? Why should anyone want to do this? How should you get ready for this as a regulator, manufacturer, authority, or…
DetailsFrom 2017-2022 the FDA offered a “Precertification (Pre-Cert) Pilot Program” to specific companies for standalone software to simplify and accelerate the approval process for digital health devices. This article summarizes the most important aspects and provides a quick overview. Precertification (Pre-Cert) Pilot Program The FDA has recognized that software The new approach The agency is,…
DetailsThreat modeling is a “mandatory” topic for all manufacturers of medical devices that contain or are software. This is because threat modeling is a structured process for the systematic analysis of IT security risks that auditors consider to be the “state of the art.” 1. Why should you use threat modeling? Reason 1: To develop secure devices…
DetailsThe process FMEA (pFMEA) is a method for the systematic analysis of risks resulting from failure modes in processes, such as device production and cleaning. Laws, such as the MDR, and standards, such as ISO 13485, require medical device manufacturers to identify and control such process risks. 1. What the pFMEA is a) The pFMEA is a…
DetailsMore and more manufacturers are using machine learning libraries, such as scikit-learn, Tensorflow, and Keras, in their devices as a way to accelerate their research and development projects. However, not all manufacturers are fully aware of the regulatory requirements that they have to demonstrate compliance with when using machine learning libraries or how best to…
DetailsWith its Safer Technologies Program (STeP), the FDA hopes to open up a new approval pathway for manufacturers of innovative medical devices. The FDA wants patients to benefit more quickly from these innovations. In this article, you can read about the simplifications and help the FDA intends to provide for you as a manufacturer and…
DetailsUnannounced audits are random sampling checks of the quality management systems by notified bodies with the aim of Initial experience with unannounced audits is now available. Update: Changes due to the MDR History of unannounced audits The emphasis on unannounced audits is a result of the breast implant scandal, after which the demand emerged to…
DetailsMany people ask about the liability of individuals, management, and the company. After all, it is not only the Medical Devices Regulations that impose fines and imprisonment. The question of liability also arises for development service providers. Liability in Germany: Differentiating between criminal and civil law Civil law: Parties involved In civil law, the question…
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