Ads
related to: medical device regulations training and development
Search results
Results From The WOW.Com Content Network
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC (MDD), which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021. The regulation was published on 5 April 2017 ...
ISO 13485. 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.
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 ...
This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
Medical Device Amendments of 1976. Long title. An Act to amend the Federal Food, Drug, and Cosmetic Act to provide for the safety and effectiveness of medical devices intended for human use, and for other purposes. Enacted by. the 94th United States Congress. Effective. May 28, 1976. Citations. Public law.
IEC 62304. IEC 62304 – medical device software – software life cycle processes [ 1 ] is an international standard published by the International Electrotechnical Commission (IEC). The standard specifies life cycle requirements for the development of medical software and software within medical devices. It has been adopted as national ...
Ads
related to: medical device regulations training and development