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 September 14, 2024, the new version of the German Health Interoperability Governance Regulation (or IOP Governance Regulation, or GIGV for short) came into force. The German Ministry of Health published a draft bill (only available in German) containing the recitals on April 24 of that year. This version of the GIGV will replace the…
DetailsMedical device manufacturers must determine the severity of possible harm to assess the risks posed by their devices. What sounds simple is very challenging in practice. This article assists in determining and documenting the severity of harm in accordance with ISO 14971.
DetailsThe SSCP (Summary of Safety and Clinical Performance) is not the only report that the MDR requires from many medical device manufacturers. In terms of content, the SSCP even overlaps with the PSUR and the PMS reports. The IVDR places almost identical requirements on the SSP (Summary of Safety and Performance). How do all these…
DetailsAQL stands for Acceptable Quality Level and is sometimes translated as “permitted reject rate.” The AQL determines when a batch of parts or products is rejected or accepted based on a random sample inspection. However, auditors regularly no longer accept the AQL. What to do? This article provides answers.
DetailsISO 14971 defines the terms “hazard” and “hazardous situation.” Nevertheless, medical device manufacturers often find it difficult to assign concrete cases to either of the two categories. This article provides help.
Poor instructions for use are a common cause of use errors that can result in harm to patients and users. Furthermore, instructions for use for medical devices and IVDs are subject to strict regulatory requirements. The MDR, the IVDR, the FDA and numerous standards establish specific requirements for the instructions for use. This article will…
DetailsEU Regulation 2017/745 (MDR) establishes the general requirements for instructions for use (IFU). Whether they can also be provided in electronic form (eIFU) is regulated by Implementing Regulation (EU) 2021/2226. We have summarized the requirements for electronic instructions for use for you.
DetailsThe standard ISO 15223-1, regulates the symbols that manufacturers are permitted to/must use for labeling medical devices. In January 2022, the EU Commission harmonized EN ISO 15223-1 as one of relatively few standards under the MDR and added it to the list of harmonized standards. This alone makes it clear how relevant labeling has become. …
DetailsIn software development, unit testing refers to the testing of software units. However, there is no common understanding of This article provides clarity.
DetailsThe correct and precise formulation of the intended purpose of medical devices and in vitro diagnostic medical devices (IVD) is crucial for their successful development and approval. However, even the definitions of terms and the distinction between intended purpose and intended use make it difficult to achieve clarity and precision. This article reveals how to…
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