Search results with tag "Technical documentation"
Structure of Technical Documentation (Medical Devices)
www.mdc-ce.deStructure of Technical Documentation 004/08.2021 (Medical Devices) ID: 2379 Page 1 of 4 The following structure is based on Regulation (EU) 2017/745 (MDR) but is also suitable for technical documentation according to Directive 93/42/EEC. 1.Device description and specification 1.1.General description of the device, its variants and its intended ...
Medical Device Directive (MDD)
www.medicaldevicesgroup.netMedical Device Directive (MDD) 93/42/EEC as modified by 2007/47/EC. Slide 2 of 37 Robert Packard, Consultant ... • CE Marking of medical devices requires technical documentation (i.e., – a Technical File or Design Dossier)—based on the device ... Dossier is the Technical Documentation plus a summary of the history of design changes for
Project Report and Technical Documentation - SourceForge
quaneko.sourceforge.netProject Report and Technical Documentation Thomas Jund <info@jund.ch> Andrew Mustun <andrew@mustun.com> Laurent Cohn <info@cohn.ch> 24th May 2004 Version 1.0. ii Abstract In this paper we present quaneko, a tool to e ciently nd data on the local computer system. The purpose of this document is the technical specication and description of the
GHTF SG1 - Summary Technical Documentation …
www.imdrf.orgSummary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of IVD Medical Devices (STED)
Commission Factsheet for Class I Medical Devices
ec.europa.euThe device must meet all applicable general safety and performance requirements set out in Annex I of the MDR. A clinical evaluation should be performed and included as part of the technical documentation. Conformity of devices against applicable requirements of the MDR should be demonstrated in the technical documentation,
MDR Conformity Assessment Routes - BSI Group
www.bsigroup.comas per Technical Documentation Sampling Plan or at the time of PSUR assessments Clinical Evaluation Report updates Updated as per Manufacturer’s clinical evaluation plan; NB to review updates as per Technical Documentation Sampling Plan or at the time of PSUR assessments Post Market Clinical Follow-Up Update Report (Article 61)
MDS G5 Guidance on Requirements for Medical Device …
sfda.gov.saclassification of the device. General 1 Medical device shall comply with the “Essential Principles of Safety and Performance” specified in Annex (1) and Annex (2). 2 Medical device manufacturer shall: − Prepare, hold and update the “Medical Device Technical Documentation” and/or “IVD Technical Documentation” that
Table of Contents European Medical Device Regulation …
ww2.orielstat.comEuropean Medical Device Regulation 2017/745 The following 175 pages were published in the Official Journal of the European Union on 5 May 2017. ... Technical documentation II 109-112 Technical documentation on post-market surveillance III 113 EU declaration of conformity IV 114
2020 Census State Redistricting Data (Public Law 94-171 ...
www2.census.govThis chapter serves as a guide for data users to both the file and the technical documentation. Novice users trying to understand how to use the documentation and the file should read this chapter first. DATA FORMAT AND ACCESS TOOLS The 2020 Census Redistricting Data (Public Law 94-171) Summary File was initially delivered to
IVDR Documentation Submissions - BSI Group
www.bsigroup.comfinding the report, confirming that the correct report has been found, confirming whether th ere have ... the Technical Documentation submitted, with components clearly labelled with name, lot number, expiry date and final draft IFU. On-goni g batch release w lli requrie, ni addtioi n to sendni g ktis to the EU Reference Laboratory as requried, ...
Q&A on in vitro diagnostic medical device conformity ...
ec.europa.euDirective 98/79/EC is being replaced by Regulation (EU) 2017/746. What changes will it ... A medical device is a device intended by its manufacturer for a medical purpose, such as treatment of ... It does not include manufacturer technical documentation, which is …
Draft Rehospitalization Technical Documentation - CMS
www.cms.govthe remainder of this report as “rehospitalization” and “ED use without hospital readmission,” respectively). These measures include home health stays beginning within 5 days of an inpatient hospital discharge and measure rehospitalization or use of the ED without readmission during the 30 days following the beginning of home health care.
EJSCREEN Technical Documentation 2014 - environmental ...
www.epa.gov7 | Page Introduction consequences resulting from industrial, governmental and commercial operations or policies. 1 (italics added) EPA’s efforts to understand EJ concerns date back at least to EPA’s 1992 report on Environmental Equity (U.S. EPA, 1992). The 1992 report documented health and exposure disparities associated with
Technical Documentation and Medical Device Regulation
www.bsigroup.comthe ‘Summary Technical Documentation (STED)’, intended to be a consistent, summarized or abridged form of the technical documentation, with sufficient detail to allow the NB to fulfil its obligations. The STED represents the status of the medical device at a specific moment of its life cycle and should be updated to correspond to the technical
Technical Documentation
www.meddev.infoCompetent Authorities and manufacturers on the technical documentation needed to meet the requirements of the medical devices Directives. Note: It is not the purpose of this Recommendation to oblige the manufacturer to re-organise existing technical documentation where this already proves appropriate and sufficient. 3 Technical Information 3.1 ...
Technical Documentation - Dell EMC US
www.emc.comEMC WHITE PAPER EMC® VPLEX™METRO CONTINUOUS AVAILABILITY AND CLUSTER WITNESS IMPLEMENTATION AND DESIGN GUIDE ABSTRACT This technical note is targeted for EMC field personnel, partners, and customers who
Technical Documentation - BERGER LAHR Servis Merkezi
berger-lahr.service-tr.comBerger Lahr drive systems are products intended for general use that conform to the state of the art in technology and are designed to elimi- nate dangers as much as possible.
Technical Documentation - ATB Sever Subotica
sever.rs2 ELECTRIC MOTORS IN EXPLOSION-PROOF PROTECTION EExe and EExd 1. GENERAL INFORMATION 1.1 INTRODUCTION Explosion-proof tree-phase induction electric motors in this catalogue, refer to the design of increased safety - EExe and flameproof enclosure - EExd.These motors are applied in industrial plants, in
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