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The 510 K premarket notification, premarket approval (PMA), design dossier under the Medical Device Directive process, regulations and procedures are delineated.
Dr Tony Cox, a former HSE advisory committee chairman, said Alton Towers staff would be questioned and documents seized, including the rollercoaster's design dossier, as well as maintenance and safety records.
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To accomplish this, the authors designed a faculty electronic dossier (e-dossier), using Blackboard technology to replace the traditional paper dossier.
This so-called Akkari-Laban dossier was designed to present their case and solicit support for their outrage.
BBC assistant political editor Norman Smith said Labour's "dossier" was designed to give people "the political heebie jeebies" given the scale of cuts required, and an attempt to paint the Conservatives as ideological when it comes to reducing spending.
Uncharacteristically, Sir John Scarlett, 'C' or Chief of MI6, baulked at signing off another "dodgy dossier" - this one designed to avoid embarrassment for the government in front of an inquiry by the Organisation for Economic Cooperation and Development OECDD) into the BAE affair.
This article describes the process of designing the faculty e-dossier and presenting it to the faculty and administrators and discussing the acceptance of this innovative change.
His first big brainstorm post-9/11 was a program known as Total Information Awareness, designed to identify potential terrorists by compiling a detailed electronic dossier on millions of Americans.
The Steele dossier was clearly a major hit on Trump designed to destroy his presidential campaign.
We aimed to design a decision tree based on a series of studies included in actual dossiers approved by competent regulatory authorities, noting that the design, execution and interpretation of pharmacokinetics studies using this type of therapy is not straightforward and presents a challenge for both developers and regulators.
The study design and methods of the included studies are to be described to ensure that the dossier contains all information relevant for benefit assessment (Section 4.2.5.1 Suppl. G-BA VerfO; Section 7.1.4 IQWiG GM 4.0).
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