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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Process validation is the verification that a process meets the requirements imposed on its process results. Learn when you must validate which processes (in the context of software) and how to ace validation. Furthermore, find out what process validation has to do with PQ, IQ, and OQ.
DetailsMedical device manufacturers are obliged to observe and comply with legal retention periods for documents and records. This article provides an overview of the regulatory requirements for the retention periods for the various document classes.
DetailsIEC 62304 has introduced the concept of safety classification to allow medical device manufacturers to adapt the effort required for software documentation to the degree of possible harm that a software defect would cause. This article will help you determine the safety classes and document compliant with IEC 62304. Update: No more presumption of conformity…
DetailsThis article describes the requirements of the in vitro diagnostic medical device regulation (IVDR) for software development and documentation. The requirements apply to software that is part of an IVD (embedded software) and to software that is an IVD itself (“standalone” software). This article also compares the software requirements of the MDR and the IVDR.
DetailsUnannounced audits are random sampling checks of the quality management systems by notified bodies with the aim of Initial experience with unannounced audits is now available.
DetailsTIR 57 is a “Technical Information Report” from the American AAMI. It is intended to assist in recognizing and controlling risks due to inadequate IT security of medical devices, thus fulfilling the requirements of ISO 14971 for risk management.
DetailsCoding guidelines are intended to promote source code that is understandable, maintainable, testable, and error-free. This article describes the regulatory requirements for coding guidelines and provides specific examples.
IEC 82304 is now available. This is a good reason to take a closer look at this standard for “health software products.”
The Health Breach Notification Rule defines when health records providers have to report which security issues to whom, within what time frame and in what form. This article provides a brief overview of the requirements of the US Federal Trace Commission (FTC).
The Federal Trade Commission (FTC) is an US agency that aims to ensure compliance with competition law and consumer protection. This article explains the circumstances that require you (e.g., as a medical device manufacturer) to comply with the FTC requirements and the specifics of these requirements. The case of Lumosity shows how radically the FTC…
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