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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On 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. Who the IT Security Guideline is aimed at The guideline is aimed at all manufacturers of medical devices (persons placing on the market, service…
DetailsThe 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. Consensus…
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. Process validation: What is it exactly? a) Definition…
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. 1. Retention periods for different classes of documents The legal requirements regarding retention periods usually distinguish between the following types…
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. Update: Changes due to the MDR History of unannounced audits The emphasis on unannounced audits is a result of the breast implant scandal, after which the demand emerged to…
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. TIR 57: Summary for readers in a hurry The AAMI TIR 57 is a guidance document…
DetailsIEC 61010-2-101 is a harmonized standard for in vitro diagnostics (IVD). IVD manufacturers can use IEC 61010-2-101 to demonstrate conformity with the general safety and performance requirements of the IVD Regulation (IVDR). The IEC 61010 family Scope of application IEC 61010 is a series of standards that formulates safety requirements for electrical equipment for measurement,…
DetailsIEC 82304 is now available. This is a good reason to take a closer look at this standard for “health software products.” IEC 82304: Why another standard? Closing the IEC 62304 validation gap IEC 62304 was launched with the claim of being applicable to all medical device software – whether standalone or embedded. However, the…
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! What distinguishes risk analysis for software from other medical devices In the case of (standalone) software, harm…
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