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
Class I software
Practical 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.
DetailsMedical Device Coordination Group (MDCG)
The Medical Device Coordination Group (MDCG) is an expert panel required by the MDR and IVDR. The MDCG is sometimes confused with another coordination group or with expert panels. You can find out how these groups are differentiated here. Read this article to find out how you are affected by the output of the MDCG’s…
DetailsRegulation 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…
DetailsDecision Support Systems as medical devices
Decision Support Systems are also increasingly being used in medicine. If they are medical devices, they must meet the legal requirements (e.g., the general safety and performance requirements). The hype surrounding Artificial Intelligence, in particular Machine Learning, and users such as Watson are raising hopes for the performance of Decision Support Systems. This article presents…
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.
DetailsComputerized Systems Validation CSV
We frequently get asked, “Do you also offer Computerized Systems Validation?” One of the reasons for the interest is certainly: Authorities and notified bodies increasingly address the Computerized Systems Validation (CSV) in audits. This article introduces regulatory requirements regarding “Computerized Systems Validation” and provides guidance on how you can best meet these requirements.
DetailsThird edition of ISO 14971 – What is changing
The third edition of ISO 14971 has been available since December 2019. This new version of ISO 14971 was published as ISO 14971:2019. It is an evolutionary development of ISO 14971:2007 and does not break with previous concepts. Manufacturers should familiarize themselves with the new and amended requirements of this standard. In December 2019, the…
DetailsIn vitro diagnostic medical device performance evaluation: 8 steps to conformity
If manufacturers don’t conduct a legally compliant performance evaluation of their in vitro diagnostic medical device (IVD), they aren’t just running the risk of problems during the authorization process: They are risking patient safety. Therefore, the IVDR sets strict requirements for this performance evaluation. Find out how the requirements of the IVDR for the performance…
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.”
