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Society for Human Resource Management. The Society for Human Resource Management (SHRM) is a professional human resources membership association headquartered in Alexandria, Virginia. SHRM promotes the role of HR as a profession and provides education, certification, and networking to its members, while lobbying Congress on issues pertinent to ...
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 ...
Staff. 36 employees. Website. www.accme.org. The Accreditation Council for Continuing Medical Education (ACCME) sets and enforces standards in physician continuing education (or "lifelong learning") within the United States. It acts as the overseeing body for institutions and organizations providing continuing medical education (CME) activities.
One of the more contentious issues related to drug safety is immunity from prosecution. In 2004, the FDA reversed a federal policy, arguing that FDA premarket approval overrides most claims for damages under state law for medical devices. In 2008, this was confirmed by the Supreme Court in Riegel v. Medtronic, Inc. [278]
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 design of medical devices constitutes a major segment of the field of biomedical engineering. The global medical device market was estimated to be between $220 and US$250 billion in 2013. [4] The United States controls ≈40% of the global market followed by Europe (25%), Japan (15%), and the rest of the world (20%).
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