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Autonomous Systems: 4 Advantages for Medical Device Manufacturers

Autonomous Systems: 4 Advantages for Medical Device Manufacturers Autonomous systems are being increasingly used in medicine as well. These autonomous systems can be, on the hand, individual medica

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Safety Assurance Cases: A Way to Shorten Painful Discussions with Auditors

Safety Assurance Cases: A Way to Shorten Painful Discussions with Auditors Are you tired of discussing whether your devices are sufficiently safe with notified bodies? Then you should use safety as

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Regulatory Science: Europe is Flying Blind

Regulatory Science: Europe is Flying Blind In German-speaking areas, regulatory science is rarely practiced systematically. And this failure creates problems for medical device manufacturers and

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ISO 27034 on Application Security: Reading It = A Waste of Time?

ISO 27034 on Application Security: Reading It = A Waste of Time? The title of ISO 27034 is “Information technology — Security techniques — Application security”. It is referenced in the BSI guideli

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Medical Device Consultant – Only A German Concept?

Medical Device Consultant – Only A German Concept? Medical device consultants play a key role in guaranteeing the safety of medical devices. However, only German medical device law (MPG, MPDG) requ

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Transfer Learning in Medical Devices: Regulatory Recklessness or an Ethical Necessity?

Transfer Learning in Medical Devices: Regulatory Recklessness or an Ethical Necessity? Transfer learning is an approach to machine learning in which models trained with a dataset from one domain (p

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Corrective and Preventive Actions

CAPA: Corrective and Preventive Actions 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 corrective ac

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Code Verifier: Is A Smartphone Enough?

Code Verifier: Is A Smartphone Enough? Code verifiers are optical measuring instruments that are used to check the quality of data matrix codes and barcodes used, for example, as unique device iden

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Why VDE-AR-E 2842-61 (Trustworthy AI Systems) Doesn’t Just Apply to Development

Why VDE-AR-E 2842-61 (Trustworthy AI Systems) Doesn’t Just Apply to Development In VDE-AR-E 2842-61 the VDE has developed a whole family of standards for trustworthy autonomous/cognitive syste

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Do You Need to Be Aware of ISO/IEC TR 29119-11 on Testing AI/ML Software?

Do You Need to Be Aware of ISO/IEC TR 29119-11 on Testing AI/ML Software? At the end of 2020, ISO published the technical report ISO/IEC TR 29119-11. Its title is “Guidelines on the testing of

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