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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1. Definition of the term UOUP (according to IEC 62366) The IEC 62366-1:2015 (the standard for “Application of usability engineering to medical devices”) introduces the term UOUP and defines it as follows: A UOUP (User interface of unknown provenance) is a user interface or parts of a user interface with an unknown development process for…
DetailsThe parameterization of software – in this context, we can also talk about customizing or configuring software – often leads to discussion, e.g., regarding responsibilities and the differentiation to in-house production. This article gives manufacturers and their customers important advice on what to look out for when parameterizing software and how to avoid the usual pitfalls.
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.
The FDA offers manufacturers the opportunity to use so-called recognized consensus standards for the approval of their devices. The US authority has published a “guidance” document on these consensus standards, presented in this article. It also describes the requirements for using the standards and the advantages for manufacturers, but also points out typical mistakes.
DetailsThe EU General Data Protection Regulation must be complied with starting at 25 May 2018, at the latest. Many companies, amongst them also medical device manufacturer and operators such as hospitals, are not adequately prepared. This article gives you a review of the main concepts and requirements of the General Data Protection Regulation and examines…
DetailsProcess 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.
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.
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