Search results
Results from the WOW.Com Content Network
English: These Regulations contain the legislative measures necessary for the implementation of three European Community Directives- Council Directive 90-385-EEC on the approximation of the laws of the Member States relating to active implantable medical devices, as amended; Council Directive 93-42-EEC concerning medical devices, as amended; and Directive 98-79-EC of the European Parliament ...
A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient.
IEC 62366 is a process-based standard that aims to help manufacturers of medical devices to design for high usability. It does not address clinical decision-making related to use of the device. The standard will replace ISO/IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability.
Chest is a peer-reviewed medical journal covering chest diseases and related issues, including pulmonology, cardiology, thoracic surgery, transplantation, breathing, airway diseases, and emergency medicine. The journal was established in 1935. It is the official journal of the American College of Chest Physicians which publishes
The Medical Device Directive—Council Directive 93/42/EEC of 14 June 1993 concerning medical devices—is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the ...
The bibliographic database (without full-text dissertations) is known as Dissertation Abstracts or Dissertation Abstracts International. PQDT annually publishes more than 90% of all dissertations submitted from accredited institutions of higher learning in North America as well as from colleges and universities in Europe and Asia.
Abstract submission involves the authors in preparing their abstracts and sending them to the conference organisers through an online form. The abstracts are either uploaded as documents (typically Microsoft Word, PDF or LaTeX) or, where graphics and tables are not required, they may simply be entered into the form as plain text. The software ...
The Medical Devices Directive (MDD 93/42/EEC) similarly lists several requirements regarding the design of a medical device. The Medical Devices Regulation (MDR (EU) 2017/745), replacing the MDD from 2021, requires information to allow the design stages applied to the device to be understood as part of the design and manufacturing information ...