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.
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…
DetailsNeither the MPG nor the MDR contain regulations on product liability, i.e., manufacturers’ liability for harm caused by defective devices. However, manufacturers should be aware that a lot of legal regulations entitle injured persons to claim compensation if a defective medical device causes harm to a patient, user, or third party. Liability may result, for example,…
DetailsThe European In Vitro Diagnostic Medical Device Regulation (IVDR) must be followed by manufacturers who wish to place in vitro diagnostic medical devices on the market in the EU. The Regulation (EU) 2017/746 In vitro Diagnostic Medical Device Regulation (IVDR) regulates the entire life cycle of in vitro diagnostic medical devices (IVDs) in the European market. The IVDR came…
DetailsThe 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?
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