The third edition of ISO 14971 has been available since December 2019. This new version of ISO 14971 was published as ISO 14971:2019. It is an evolutionary development of ISO 14971:2007 and does not break with previous concepts. Manufacturers should familiarize themselves with the new and amended requirements of this standard. In December 2019, the…
DetailsA Quality Assurance Agreement (QAA) is a contract between companies such as medical device manufacturers and their suppliers (subcontractors). In these contracts, both parties regulate which obligations the suppliers must fulfill regarding the quality of the devices and services supplied. Find out in this article what content a Quality Assurance Agreement should contain and when…
DetailsOn November 21, the Johner Institute, together with TÜV SÜD, TÜV Nord, and with the support of Dr. Heidenreich (Siemens), published a guideline on IT security specifically for medical device manufacturers.
Medical 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.
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.
DetailsSoftware risk analysis depends on the following: Software itself cannot cause harm. It always happens via hardware or people. However, this does not mean there is no need for risk analysis in software. The opposite is the case!
The FDA MAUDE database provides information on the “Manufacturer and User Facility Device Experience.” It thus corresponds roughly to the database used by the BfArM to publish manufacturer reports on risks.
Fault Tree Analysis is a procedure used to search for unknown causes of known effects (in the case of medical devices, harms or hazards). It, therefore, counts as a top-down procedure in risk analysis.
A medical device can cause harm to patients, users, or third parties. The manufacturer must identify this harm to determine the device’s risks and control them. This article provides guidance on how to determine and document harm in accordance with ISO 14971 and how to use the term “harm” correctly.
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