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Creating Engineers and Products for the Healthcare Industry

A resource on the topic of education, careers and product development in the medical device field

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“The mere practical architect ( engineer ) is not able to assign sufficient reasons for the forms he adopts; and the theoretic architect ( engineer ) also fails, grasping the shadow instead of the substance. He who is theoretic as well as practical, is therefore doubly armed; able not only to prove the propriety of his design, but equally so to carry it into execution.”

The Architecture of Marcus Vitruvius Pollio, trans. Joseph Gwilt (London, 1826), pp 3-4

Biomedical Product Websites

Medgadget
The Healthcare IT Guy

BMET Specific Sites

BMET Wiki

FDA Guidance

Design Control Guidance For Medical Device Manufacturers

JCAHO site

JCAHO

Patient Safety

Patient Safety and Quality
Making Health Care Safer

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FDA Recalls

Gilenya (fingolimod): Drug Safety Communication - Severe Worsening of Multiple Sclerosis After Stopping the Medicine November 20, 2018
Implanted Pumps: Safety Communication - Use Caution When Selecting Pain Medicine for Intrathecal Administration November 14, 2018

Entry Level BME Jobs

Sr. Product Development Engineer - Ondine Research Laboratories - Bothell, WA November 20, 2018
Operations Support Specialist - General Electric - Glen Allen, VA December 4, 2018

BMET Jobs

Clinical Engineering Manager - Ashland, KY - Aramark - Huntington, WV December 3, 2018
Biomedical Equipment Technician I - Healthcare Technologies - Aramark - Huntington, WV November 20, 2018

Recent Prosthetic Patents

Devices and a kit for improving the function of a heart valve November 10, 2015
Intervertebral spacer September 22, 2015

Commercial Bioreactor Technology

I guess the piece I dislike the most about ... July 12, 2016
MKArch gives and excellent up thumb view on... May 30, 2014
Company has IP related to plant based biolo... May 1, 2012

CDRH Device Information

GE Healthcare Recalls CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA @US has identified this as a Class I Recall, the most serious type recall. Read more about the recall here: https://go.usa.gov/xE383 #MedicalDevice #FDApic.twitter.com/X4IprwU8R2 December 14, 2018
#ICYMI: @US_FDA cleared a mobile medical app to help those with #opioid use disorder stay in recovery programs. Read more about the clearance here: https://go.usa.gov/xE3ke #FDA #MedicalDevice December 14, 2018
#ICYMI: Jeff Shuren, Director of the Center for Devices & Radiological Health, released a statement on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data. Read the statement here: https://go.usa.gov/xE3kf #MedicalDevice December 14, 2018

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