Discover new articles every week on the topics of regulatory affairs (including international approval and FDA approval), QM systems (e.g., ISO 13485), risk management (ISO 14971), software development (IEC 62304), IT security, clinical evaluation, usability engineering (IEC 62366-1), and systems engineering (including IEC 60601-1, ISO 10993) - also for IVD medical devices.
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The EU Data Act came into force in December 2023. It aims to create a new legal framework for handling data that will not only affect US tech giants. The EU Data Act will have an impact on many companies that process data, including medical device manufacturers. This article will help you assess:
DetailsDirective 2014/53/EU (Radio Equipment Directive (RED)) applies to devices that use Wi-Fi or RFID, for example. Medical devices that send a radio signal because they connect to the internet or are operated remotely also need to demonstrate conformity with the RED before being marketed. In this article, learn more about
DetailsThis FAQ provides answers to the most common questions that companies such as medical device manufacturers have about quality management systems (QM systems) and ISO 13485.
Outsourcing risk management to service providers. Wouldn’t that be convenient? But is that allowed? And how much sense does it make anyway? Conversely, what should you as a service provider not be burdened with under any circumstances? This article provides the answers. It suggests how manufacturers and service providers can divide their activities and gives…
DetailsLaws and standards require medical device manufacturers to compile a Software Bill of Materials, the SBOM. However, standardized SBOM formats are not always sufficient to meet these requirements. In particular, medical device manufacturers who do not supply and use SBOMs for their software are no longer accepted in the market. Here are the reasons.
DetailsThe Medical Device Regulation (MDR) (like the Medical Device Directive (MDD) and thus the Medical Device Act before it) requires manufacturers to comply with life cycle processes for their software. IEC 62304 and IEC 82304 also refer to software life cycle processes. But what is a software life cycle?
1. Documentation Level: End of Level of Concern On June 14, 2023, the FDA released the guidance document Content of Premarket Submissions for Device Software Functions. This document replaces the guidance document introducing the Level of Concern and only distinguishes between two classes.
DetailsSoftware maintenance is the phase in which software is further developed, e.g., with the objective of According to the FDA, 79% of all bugs occur during software maintenance. Accordingly, some regulations address this topic.
DetailsGLP (Good Laboratory Practice) defines requirements for a quality assurance system for non-clinical health and environmental safety tests. It also describes the organizational procedure and conditions under which laboratory tests are planned, carried out, and monitored. GLP also covers the record and reporting of. In this article, you can read which requirements medical device manufacturers…
DetailsCompanion Diagnostics (also known as CDx) are used together with a medicinal product. Physicians use them, for example, to make sure that a particular medicinal product is actually suitable for a patient. This means that CDx play a particularly important role in personalized medicine. As the Companion Diagnostic and the medicinal product are inseparably linked,…
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