newsletter - June 2024
Fabiola Hartung-Linz
??#1 | MEDTECH | MDR | IVDR | QMS | AI | REGULATORY&CLINICAL AFFAIRS | SOFTWARE | MEDICAL APPS & DiGA | DIGITIZATION | CYBERSECURITY | ESG/CSR |?+491733296833 | [email protected] | ??LOVE TO SUPPORT YOU??
Practical implementation of artificial intelligence requirements
AI and machine learning are conquering the world of medical devices. These innovative technologies are not only being used in health software such as SaMD, but are also increasingly finding their way into devices and systems as embedded software. While the FDA has already approved a number of AI/ML-based medical devices in the USA, Europe is somewhat more hesitant. But what do manufacturers in this country actually have to consider if they want to integrate these state-of-the-art achievements into their products? Our article sheds some light on this: it deals with the expansion of the QM system and its processes, additional activities in the software life cycle processes as well as in clinical evaluation and usability assessment.
ISO 18562 standard series – Biocompatibility evaluation of breathing gas pathways in healthcare applications
ISO 18562 standard series – Biocompatibility evaluation of breathing gas pathways in healthcare applications
Determining and assessing the biocompatibility of medical devices and their component materials is of great importance for ensuring product safety. Any negative impact on patients in their environment should be avoided. The ISO 18562 series of standards addresses the risk of transmission of potentially hazardous substances to the patient via the gas pathway.
The biological evaluation of medical devices is regulated by the international series of standards ISO 10993 – “Biological evaluation of medical devices”. It currently consists of 18 individual standards as well as specific technical reports and additional guidelines. A new edition of?ISO 10993-1 “Evaluation and testing as part of a risk management process”?was published in October 2018.
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Events & Dates
InnovationForum Medizintechnik 2024
Tuttlingen | 17, October 2024
SAVE THE DATE and book your ticket
Before innovation comes the idea. Inspiration precedes the idea. Communication before inspiration. Before communication, contact. At this year's forum, we are once again offering you plenty of opportunities to do just that. Get to know pioneering products and processes, new methods and materials. Gain insights and inspiration from presentations and discussions. Our experts look forward to welcoming you to our stand D1.