PPT-E.H.R. Medical Device Implementation

Author : lois-ondreau | Published Date : 2016-05-21

Trinity Healthcare Alexandra Leaden Dernell Wade Hong Nguyen National University HTM 660 Systems Management and Planning Professor S Leonard 26 March 2013 Molokai

Presentation Embed Code

Download Presentation

Download Presentation The PPT/PDF document "E.H.R. Medical Device Implementation" is the property of its rightful owner. Permission is granted to download and print the materials on this website for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.

E.H.R. Medical Device Implementation: Transcript

Trinity Healthcare Alexandra Leaden Dernell Wade Hong Nguyen National University HTM 660 Systems Management and Planning Professor S Leonard 26 March 2013 Molokai Trinity Healthcare is situated in a small and quiet town within miles of beautiful beaches in Molokai It is . devices. in. . Australia. Overview. Comparing medicines and medical devices. What is a medical device?. Statistics on patients requiring medical devices. How does a medical device get to market?. The benefit versus risk approach. Trevor Ivanov. Description. A hand held device that can hold multiple white board markers, an eraser, and has a laser pointer. The markers hermetically seal such that caps are not needed. An eraser attaches to the bottom and can be removed from the caddy for use. Gary Quinn, CPPM. University of Texas. Southwestern Medical Center. What is Medical/Scientific Equipment?. Equipment used in a medical or scientific lab. Equipment used to treat patients. Human. Animal. . Class 8 Clean Room . . Controlled White Space. . Controlled Molding. Secondary Operations. . IQ/OQ/PQ Validations. . Device Packaging Solutions. . Decoration Solutions. . SPC . Monitoring & Controls. Gary Quinn, CPPM. University of Texas Southwestern Medical Center. What is Medical/Scientific Equipment?. Equipment used in a medical or scientific lab. Equipment used to treat patients. Human. Animal. Trevor Ivanov. Description. A hand held device that can hold multiple white board markers, an eraser, and has a laser pointer. The markers hermetically seal such that caps are not needed. An eraser attaches to the bottom and can be removed from the caddy for use. Air, water, food… mobile devices. Mobile devices are now an integral part of our lives. 72%. growth in worldwide . smartphone. sales in 2010. 400x. September 2009 - . 0.02%. January 2011 - . 8.09%. Joshua Price | August 2, 2018 . 1. Are You Affected by Implantable Medical Devices?. Artificial Hips and Knees. 1.05 million. new artificial hips and knees in the US every year. Pacemakers. 188,700. new pacemakers in the US every year. . Class 8 Clean Room . . Controlled White Space. . Controlled Molding. Secondary Operations. . IQ/OQ/PQ Validations. . Device Packaging Solutions. . Decoration Solutions. . SPC . Monitoring & Controls. Rene van de Zande. EMERGO | . President & CEO. 1 512 327 9997. rvz@emergogroup.com. March 31, 2016. New European Medical Device Legislation. . – Two Drafts: MDR (12040/15) and IVDR (12042/15). Trevor Ivanov. Description. A hand held device that can hold multiple white board markers, an eraser, and has a laser pointer. The markers hermetically seal such that caps are not needed. An eraser attaches to the bottom and can be removed from the caddy for use. What Students Will Do:. Discuss requirements with clinical collaborator. – Design solution. – Fabricate solution. – Test solution in simple model. – Redesign until satisfactory. Deliverables:. 1 MDCG 20181 Rev.Guidance on BASIC UDIDI and changes to UDI April2021This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/ (MDSAP). Suzan S. Davis. . President & CEO . Global Regulatory Partners-LLC. 1. Agenda. What is IDMRF . What is MDSAP . MDSAP Benefits .

Download Document

Here is the link to download the presentation.
"E.H.R. Medical Device Implementation"The content belongs to its owner. You may download and print it for personal use, without modification, and keep all copyright notices. By downloading, you agree to these terms.