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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People often talk about the approval of medical devices, even if something else is meant – sometimes a certificate of conformity, sometimes a “clearance,” sometimes a successfully completed conformity assessment procedure. Terms like “MDR approval” are even misleading. This article clarifies what a medical device approval means and when manufacturers need one in the first…
DetailsA lot of medical device manufacturers see the international authorization of their device as a potential hazard: the opportunities offered by new markets are offset by hard-to-calculate risks as well as the time and costs required for these authorizations. The five steps presented in this article will help manufacturers to manage these risks better. And this is…
DetailsManufacturers of medical devices, as well as manufacturers in all other life science sectors, such as the pharmaceutical industry, are required to carry out a regular “regulatory update.” Because as strange as it sounds, regulatory requirements oblige manufacturers to continuously monitor and evaluate changes to regulatory requirements and take any necessary measures. Keeping track of…
DetailsMedical device and IVD manufacturers must distinguish the concepts of “abnormal use,” “foreseeable misuse,” “errors in normal use,” and “misuse.” This is a prerequisite for understanding and complying with ISO 14971 and IEC 62366 requirements. Even the measures that manufacturers must take depend on the type of use.
DetailsThe Medical Device Coordination Group (MDCG) has drafted a guidance document that describes how manufacturers should place their class 1 medical devices on the market in order to comply with the MDR. The title of the document is “Guidance Notes for Manufacturers of Class I Medical Devices”. This article provides a summary of the document and gives…
DetailsChemical characterization according to ISO 10993-18 is a central component of the biocompatibility evaluation according to ISO 10993-1 and, thus, a prerequisite for the approval of medical devices. It is used to identify unknown substances in medical devices to carry out a toxicological risk assessment. This article provides an overview of
Details“Remediation” is often synonymous with maximum stress: Notified bodies or authorities such as the FDA have discovered significant deviations that must be remedied with the highest priority and without regard to the workload of employees or budgets. This article will help you to complete such “remediation projects” in such a way that
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The use of CMR substances is strictly regulated. The MDR also regulates CMR substances and places strict requirements on medical device manufacturers. This article helps to fulfill these requirements.
DetailsIn order to classify their substance-based medical device as such and not as a medicinal product, manufacturers often have to prove that complex ingredients work primarily through physical mechanisms. This article provides assistance.
DetailsISO/IEC 42001 is titled “Information technology – Artificial intelligence – Management system.” The first medical device manufacturers have set out to be certified according to this standard. But are the efforts required to do so justified? Does ISO/IEC 42001 help to meet the requirements of the AI Act? This article provides answers.
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