NEWS Administration

Active Surveillance of Medical-Device Safety

Registry-Based Prospective, Active Surveillance of Medical-Device Safety Resnic FS, Majithia A, Marinac-Dabic D, Robbins S, Ssemaganda H, Hewitt K, Ponirakis A, Loyo-Berrios N, Moussa I, Drozda J, Normand S-L, Matheny ME A strategy of prospective, active surveillance of a clinical registry rapidly identified potential safety signals among recipients of an implantable vascular-closure device, with initial alerts occurring within the first …

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BIOCOMPATIBILITY OF PLASTICS

  The International Organization for Standardization (ISO) presents widely adopted medical device guidelines that are aimed with a keen focus towards risk management. Biocompatibility testing for these devices and device components is addressed by ISO standard 10993. RESINATE 2017 Well-defined material characterization is a fundamental requirement in biocompatibility assessment. This evaluation consists of chemical, mechanical, …

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Changes to ISO 13485 2016 for Medical Device Manufacturers, Designers

Published early in 2016, ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes establishes a new international framework to mitigate risk and produce effective medical devices. Christine Berard As the new standard now clarifies that a company’s QMS “shall meet customer and applicable regulatory requirements for safety and performance,” the time …

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ESC/EACTS Guidelines for the management of valvular heart disease 2017

2017 ESC/EACTS Guidelines for the management of valvular heart disease European Heart Journal, Volume 38, Issue 36, 21 September 2017, Pages 2739–2791 The Task Force for the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) The disclosure forms of all experts involved in …

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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 nutzen kann. Ein heute 82-jähriger …

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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 given here is checked thoroughly …

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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 thoroughly by “Implant-Register”. However we …

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