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11 de may. de 2021 · Five themes emerged: lack of awareness of identifying information on implanted devices; value of information on implanted devices; varying trust with sharing device information; perceived risk with sharing device information; and lack of consensus on a systematic process for tracking implanted devices. Discussion.
5 de mar. de 2021 · A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose. Fact sheets. Databases and tools. Initiatives and groups. Resolutions and decisions.
1 Purpose of medical device classification. The classification of medical devices in use by the EU medical device legislation is a risk-based system taking into account the vulnerability of the human body and the potential risks associated with the devices.
1 de dic. de 2018 · Medical device patient information leaflets and implant cards V17 .December 2021 Page 8 of 36 . Note . While these devices are excluded from the statutory requirement to provide patient information materials, the TGA strongly encourages manufacturers and sponsors to provide patient information materials for these devices as a matter of best ...
medical devices that prioritises transparency and patient access to information. With these goals in mind, the Regulation introduces a new requirement for implantable medical device manufacturers to provide an ‘implant card’ (IC), offering patients easy access to all relevant information concerning the device with which they have been ...
25 de sept. de 2019 · 76 Altmetric. Metrics. Abstract. Post-market medical device surveillance is a challenge facing manufacturers, regulatory agencies, and health care providers. Electronic health records are...
1 de mar. de 2020 · This article discusses key concepts in the guidance document, in addition to providing lessons learned from the use of PPI for medical device regulatory applications to date and identifying new opportunities to leverage PPI to elevate the patient voice in the medical device product life cycle. Previous. FDA. medical devices. patient preference.
