Digital transformation of notified bodies
The digital transformation of notified bodies will transform the medical device ecosystem over the next few years. This article describes
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Regulation as Code: The end of regulation as we know it
Regulators 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…
DetailsFDA Software Precertification (Pre-Cert) Pilot Program
From 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.
DetailsThreat modeling – An introduction
Threat 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.”
The post-production phase: Not only relevant for ISO 14971
One of the most common deviations found during audits is related to the so-called “post-production phase”.
Validation of machine learning libraries
More 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…
DetailsThe FDA’s Safer Technologies Program: Faster access to the US market?
With 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 by notified bodies
Unannounced 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.
DetailsHealth Breach Notification Rule
The Health Breach Notification Rule defines when health records providers have to report which security issues to whom, within what time frame and in what form. This article provides a brief overview of the requirements of the US Federal Trace Commission (FTC).
Federal Trade Commission FTC: for medical device manufacturers?
The Federal Trade Commission (FTC) is an US agency that aims to ensure compliance with competition law and consumer protection. This article explains the circumstances that require you (e.g., as a medical device manufacturer) to comply with the FTC requirements and the specifics of these requirements. The case of Lumosity shows how radically the FTC…
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