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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In 21 CFR part 11, the FDA establishes its requirements for electronic records and signatures, which also apply to medical device manufacturers. A lot of companies print everything out on paper and then sign it by hand to circumvent the requirements of part 11. Is this really necessary?
DetailsThe European legislation defines systems and procedure packs and distinguishes between different configurations. The regulatory requirements placed on the manufacturer are heavily dependent on these configurations. This article will explain to you what legislators understand by systems and procedure packs, what the most important legal requirements are for manufacturers, and what common mistakes you should avoid.
DetailsElectronic and digital signatures should be considered on an equal level to handwritten signatures (“wet ink”). The requirements that need to be fulfilled depend on the extent of the binding force that is to be achieved and so depend on the document that is to be signed. This article explains
DetailsThe term “sampling kit” is not defined by the IVDR or any other regulation. Nevertheless, there are (indirect) regulatory requirements that IVD manufacturers and medical laboratories must be aware of and consider. The requirements depend on the particular constellation. This article presents five constellations. It provides clarity and helps to avoid regulatory hassles and minimize…
Details“Follow the PICO scheme.” This is the recommendation of many auditors and reviewers, as well as some regulatory documents (such as MDCG guidelines and MEDDEV 2.7/1 rev.4), regarding precise medical literature searches. Read in this article,
DetailsConducting clinical studies in Australia is not on the radar of many medical device manufacturers. However, good reasons exist to consider this continent for clinical studies or investigations. Yet manufacturers should also be aware of Australia’s regulatory requirements and specific disadvantages.
What MDR and IVDR confuse and why you should not talk about CAPA. The FDA (in 21 CFR part 820 – QSR) and ISO 13485 differentiate between Unfortunately, the MDR and IVDR do not clearly differentiate between these concepts. Some manufacturers also believe they can combine corrective and preventive actions into one single CAPA process. But…
DetailsDeviations, nonconformities, errors, findings, observations, and other terms are often used mistakenly synonymously. Even standards explicitly contradict each other when defining individual terms. This article clarifies,
DetailsThis article will help you ensure that you will still be able to offer in-house IVD (also called Laboratory Developed Tests, LDTs) under the IVDR and will explain the three options open to you avoiding legal disputes. In-house IVD are a type of in vitro diagnostic test. But do regulatory requirements such as the IVDR also…
DetailsAn FDA registration is a legally required registration of “establishments” (such as medical device manufacturers) in an FDA database. The FDA registration should not be confused with the UDI registration in the GUDID database or even an FDA approval. This article answers the most important questions and helps to avoid the most common mistakes in FDA registrations.
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