Verification and validation: Differences and definitions
What is the difference between verification and validation, and how are these terms defined? Even standards and regulations use the terms incorrectly or misleadingly. This article
DetailsSummative evaluation: The following points are essential
The term summative evaluation can be translated as “final evaluation.” A summative evaluation checks at the end of the development phase whether users can operate a device or a user interface safely. This article provides an overview of the regulatory requirements for the “summative evaluation” (sometimes also referred to as “summative assessment“) and gives you…
DetailsISO 10993-17: What the standard has changed and now requires from manufacturers
The ISO 10993-17 standard is part of the ISO 10993 series of standards on biocompatibility. ISO 10993-17 describes the procedures for Toxicological Risk Assessment. In the fall of 2023, a comprehensive standard revision was published after over 20 years. Medical device manufacturers should know, This article will help.
DetailsRisk management in hospitals and at other operators
Laws require risk management in hospitals, especially in order to improve patient safety. Nevertheless, many hospitals find this difficult. This article presents the most important regulatory requirements and provides tips for implementation.
DetailsQualification and classification of IVD software
The qualification and classification of IVD software determine how and how quickly IVD manufacturers can bring their software to market and what costs arise for “approval.” This article will help you correctly qualify and classify IVD software, thereby avoiding regulatory problems and the resulting costs and delays.
DetailsApproval of IVDs (in vitro diagnostic medical devices) in the EU
In vitro diagnostic medical devices (IVDs) are medical devices used to analyze samples derived from the human body. Typically, these products are reagents, kits, instruments, and devices. Software can also be considered as an IVD regarding its intended purpose. When “approving IVDs,” manufacturers must comply with many regulations, laws, and standards.
DetailsThe Clinical Evaluation Plan
Including a free download of the chapter structure for the Clinical Evaluation Plan The Clinical Evaluation Plan is one of the most complex documents in the technical documentation. Alongside the Clinical Evaluation Report, the Clinical Evaluation Plan (CEP) is the document most frequently criticized by notified bodies. Even experienced clinical experts typically need 60 working…
DetailsBreakthrough Devices Program der FDA
The Breakthrough Devices Program is an approval process for medical devices, and the FDA aims to enable seriously ill patients to gain faster access to novel medical devices. The authority published a “Guidance Document” in December 2018. This article explains
DetailsQMSR: The end of 21 CFR part 820?
In 21 CFR part 820, the FDA formulates the requirements for the quality management systems of medical device manufacturers, among others. Thus, 21 CFR part 820 (Quality System Regulation QSR) is or was the counterpart to ISO 13485.
Pass an FDA inspection with confidence
For many manufacturers of medical devices, an FDA inspection is associated with great stress. Many companies are aware of the possible consequences, such as a public warning letter and even criminal prosecution. But they often don’t know how to avoid these consequences without shutting down the entire company for days. This article shows how This…
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