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Vanguard AG - Your Partner for Medical Reprocessing
- https://www.vanguard.de/en/home/
- Medical remanufacturing restores a used medical device to “as new” functional and safety standard with matching warranty. Medical remanufacturing enables a circular economy within the medical device …
Legal Framework: Germany - AMDR
- https://amdr.org/2021/03/legal-framework-germany/
- The legal basis for reprocessing under German law (MP Betreiber V) changes on May 26 2021 and will be replaced by medical remanufacturing in accordance with MDR. There are two options: 1) …
National rules on reprocessing of single-use devices - Public Health
- https://health.ec.europa.eu/medical-devices-topics-interest/reprocessing-medical-devices/national-rules-reprocessing-single-use-devices_en
- EU countries have the obligation to notify the European Commission of the national provisions on reprocessing of single-use devices introduced by Article 17 (3) of …
Reprocessing Cardiology Devices - Reviewing 15 Years of …
- https://www.ecrjournal.com/articles/reprocessing-cardiology-devices-reviewing-15-years-experience-germany
- Reprocessing Cardiology Devices - Reviewing 15 Years of Experience in Germany Patient Safety. Vanguard AG, the European market leader in the reprocessing of single …
Hygiene Requirements for the Reprocessing of …
- https://www.rki.de/DE/Content/Infekt/Krankenhaushygiene/Kommission/Downloads/Hygiene_Requirements_Medical_Devices_2012.pdf?__blob=publicationFile
- The reprocessed medical device must be perfectly functional, in line with its intended use, and guarantee all -relevant requirsafety ements without restrictions. The entire …
Medical Remanufacturing - Vanguard AG
- https://www.vanguard.de/en/devices/medical-remanufacturing/
- Medical remanufacturing restores a used medical device to “as new” functional and safety standard: The device is disassembled; All components and separate parts are tested; A …
An Overview of Medical Device Law in Germany - md …
- https://www.md-institute.com/en/reprocessingmedical-devices.html?file=files/cto_layout/press-releases/medical-technology/processing-medical-devices/An-Overview-of-Medical-Device-Law-in-Germany.pdf
- on processing medical devices on medical device reps In addition, there are provisions in national medical device law on the performance of clinical trials or supervision by the …
Public Health
- https://health.ec.europa.eu/medical-devices-topics-interest/reprocessing-medical-devices_en
- Public Health
Home - AMDR
- https://amdr.org/
- Medical device reprocessing has become one of the most celebrated supply chain cost reduction strategies for hospitals. This is because reprocessing uniquely makes it …
Reprocessing of Reusable Medical Devices | FDA
- https://www.fda.gov/medical-devices/products-and-medical-procedures/reprocessing-reusable-medical-devices
- Reprocessing of Reusable Medical Devices Reusable medical devices are devices that health care providers can reuse to diagnose and treat multiple patients. …
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