ISO 13485 – Guide to requirements and content
Anyone involved in the development of software medical devices is certainly no stranger to the term “Quality management system” (QMS). You may also have heard of ISO 13485 in this context. ISO 13485 is a standard that defines the requirements for a quality...
NUB as Cost Reimbursement for Software Products in Hospitals
Even today, hospital operations without IT are hardly conceivable, as hacker attacks unfortunately often demonstrate. However, digital innovations such as AI-supported diagnostic software and clinical decision support systems promise to fundamentally improve patient...
Guide: Is your software a medical device?
That a pacemaker should be a regulated medical device is obvious. However, with software, especially apps, the ambiguity is greater. Software must also be classified as a regulated medical device under the Medical Device Regulation (MDR) if it is used for specific...
MDR Risk Class I vs. IIa: Differences for software medical devices
At the beginning of the development of a software medical device, the central question is: Which risk class applies to my product? Risk classification has serious implications and significantly influences the cost and time frame of product development. In extreme...
Approving software medical devices without quality management and regulatory requirements?
The Medical Device Regulation (MDR) poses many challenges for manufacturers of software medical devices. In addition to establishing a quality management system (QMS) and preparing technical documentation, manufacturers face regulatory liability risks. For many...
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