NEWS on implant administration
GDPR and Medical Devices
What Is GDPR's (General Data Protection Regulation) Effect On Medical Devices? K Barchie Rights provided to data subjects reinforced via GDPR are: The right to be informed of the type of processing of their data that will be taking place The right to access and review the data that is...
Regulation on Medical Devices Europe (MDR) causes unrest
Regulation on Medical Devices Europe (MDR) causes unrest ÄrzteZeitung A deficit of qualified employees and the reduced number of notified bodies could result in a shortage of new registrations, hindering manufacturers to introduce new products. This is a post of a scientific or business information. The information given here is checked...
German Ministry of Health announces national Implant-Register
German Ministry of Health announces law for national implant-register Ärzteblatt Following an inquiry of the german party FDP the ministry of health in Germany announced a blueprint for an implant-register to improve reliability of implants and medical treatment. This is a post of a scientific or business information. The information...
FDA: Reporting Allegations of Regulatory Misconduct
The FDA encourages people submitting allegations to include supporting information and contact information in case additional information is needed for the FDA to understand the allegation and act on the report; however you can choose to submit a report anonymously. The FDA will not share your identity or contact information...
Digital Health Innovation Plan (FDA)
FDA can help encourage digital health innovation by redesigning our policies and processes and modernizing our tools so that they match the needs of digital health technology, and providing clarity on those policies and processes so that manufacturers and developers know what they need to do. We have designed this...
Genium knee joint – insurance (german)
Krankenkasse muss Kosten für Genium-Kniegelenk tragen Hessisches Landessozialgericht Das LSG Darmstadt hat entschieden, dass ein 82-jähriger Versicherter einen Anspruch auf eine Versorgung mit einem Genium-Kniegelenk anstelle mit einem C-Leg-Beinprothesensystem haben kann, wenn ihm das kostenaufwändigere Hilfsmittel einen wesentlichen Gebrauchsvorteil im Vergleich zur kostengünstigeren Alternative bieten kann, den er auch tatsächlich...
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