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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Unannounced 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…
DetailsThe 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. Content of the FDA MAUDE database The FDA MAUDE database contains information on Regulatory background Obligation to evaluate Manufacturers are obliged to conduct adequate…
DetailsIEC 60601-1 defines a PESS, a Programmable Electronic Subsystem, as a system based on one or more central processing units, including their software and interfaces. The standard does not reveal what it means by system; in this context, it is a medical device component. For this, IEC 60601-1 sets out specific requirements for the PESS.…
DetailsThe software architecture documentation primarily serves these objectives: Fast, effective, and plannable software development will succeed if the task (to develop software that meets the software requirements) is broken down into solvable subtasks, which can be distributed among many developers. The prerequisite for this is a precise (documentation of the) software architecture, which is unfortunately…
DetailsBlack box testing is when test cases are derived solely from the specification of the object to be tested (product, component). White box testing, on the other hand, derives the test cases from the internal structure of the object, e.g., from its source code or software architecture. Unfortunately, many medical device manufacturers neither specify the test…
DetailsMany people ask about the liability of individuals, management, and the company. After all, it is not only the Medical Devices Regulations that impose fines and imprisonment. The question of liability also arises for development service providers. Liability in Germany: Differentiating between criminal and civil law Civil law: Parties involved In civil law, the question…
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