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Download as PDF; Printable version ... Design history file, ... ISO 13485 is a voluntary standard that contains section 7.3 Design and Development recommending which ...
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
Model-based definition (MBD) is a method of product specification using elements within 3D models as defined by ASME Y14.41-2012. ASME Y14.41-2012 is based upon ASME Y14.5-2009 symbols and definition methods, such as Geometry Dimensioning and Tolerancing (GD&T).
Design History File (DHF) The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of medical device to establish a Technical file, similar to a device master record. The EU medical device regulation requires a manufacturer of a medical device to maintain a Technical documentation.
A technical file is a set of documents that describes a product and can prove that the product was designed in accordance with the requirements of a quality management system. All products that have a CE mark must have a technical file which must contain the information that proves that the product conforms with the EU directives and ...
ISO 9000:2005 provides information on the fundamentals and vocabulary used in quality management systems. ISO 9004:2009 provides guidance on a quality management approach for the sustained success of an organization. Neither of these standards can be used for certification purposes as they provide guidance, not requirements.
In 2012 December, JT has been officially published as ISO 14306:2012 (ISO JT V1) [3] as a 3D visualization format, based on version 9.5 of JT specifications released by Siemens Digital Industries Software. Through this publication via ISO, for the first time a completely neutral and royalty-free specification of JT was available.
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.