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A simplified example of information flow within a technical data management system TDMS functions are similar to that of conventional archive functions in concepts, except that the archived materials in this case are essentially engineering drawings, survey maps, technical specifications , plant and equipment data sheets, feasibility reports ...
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.
OpenAPS is a set of development tools and documentation to support a DIY implementation of an artificial pancreas for people with Type 1 Diabetes. Common setups include the interfacing of CGMs, Insulin Pumps, and Raspberry Pi devices. It is released under the MIT license, but compatible medical devices are proprietary. [59]
The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of a medical device to establish a technical file (medical device file, device master record, design dossier, or device master file). Annex II and III of the EU medical device regulation (MDR) and of the In-vitro Diagnostic Regulation (IVDR) contain an overview of the contents and ...
The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 ...
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 ...
In December, 2010, a notice was released by Health Canada further clarifying the definition, classification and licensing requirements of software regulated as a medical device. For example, software used to transmit data from a medical device, or software that analyzes data from a medical device and makes diagnostic or treatment decisions ...
Point of care (POC) documentation is the ability for clinicians to document clinical information while interacting with and delivering care to patients. [10] The increased adoption of electronic health records (EHR) in healthcare institutions and practices creates the need for electronic POC documentation through the use of various medical devices. [11]