NEWS on implant administration
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...
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...
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...
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...
Green light for transplant registry in Germany
Grünes Licht für Transplantationsregister Dtsch Arztebl 2016; 113(29-30): A-1361 / B-1149 / C-1129 German politics agreed to install a transplant register. Richter-Kuhlmann, E-A.
CANADA: Medical Device Single Audit Program Transition Plan
CANADA: Medical Device Single Audit Program Transition Plan (FAQ) Health Canada clarification about the MDSAP Transition Plan from stakeholders as Health Canada moves towards the Medical Device Single Audit Program (MDSAP) Quality Systems Division, Medical Devices Bureau, Health Canada
Criminals fake implants with 3-D-tools
Darum gefährden 3-D-Drucker unsere Gesundheit Die Welt, Germany Criminals fake implants, protheses and pacemaker with 3-D-tools Carsten Dierig
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