www.amazon.com/author/paulbabicki
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Medical Device Class (MDC) via whatis.com
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Medical
device class (MDC) is a regulatory category defined by the United
States Food and Drug Administration (FDA). In the United States, the FDA
has the authority to regulate medical devices before and after they reach the
marketplace.
A medical device's class determines what
controls have been put in place to manage risk and assure patients, doctors
and manufacturers that the device will operate safely and effectively. Class
I includes devices with the lowest risk and Class III includes those with the
greatest risk.
Class I Medical Devices - devices in this
class have a simple design and pose little to no potential risk of injury or
illness to patients or operators. Examples of devices in this category
include oxygen masks, examination gloves and tongue depressors.
Class II Medical Devices - devices in this
class have a more complex design and pose minimal risk of injury or illness
to patients or operators. Examples of devices in this category include wheel
chairs, X-ray machines and cardiac monitors.
Class III Medical Devices - devices in this
class have an intricate design and support or sustain human lives. Devices in
this category are capable of posing substantial risk of injury. Examples of
devices in this category include heart valves, implanted pacemakers and cerebral
simulators. The FDA requires Class III devices to be designed with a balance
between ease-of-access and strong cybersecurity controls.
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In addition to this blog, Netiquette IQ has a website with great assets which are being added to on a regular basis. I have authored the premiere book on Netiquette, “Netiquette IQ - A Comprehensive Guide to Improve, Enhance and Add Power to Your Email". My new book, “You’re Hired! Super Charge Your Email Skills in 60 Minutes. . . And Get That Job!” has just been published and will be followed by a trilogy of books on Netiquette for young people. You can view my profile, reviews of the book and content excerpts at:
www.amazon.com/author/paulbabicki
Anyone who would like to review the book and have it posted on my blog or website, please contact me paul@netiquetteiq.com.
In addition to this blog, I maintain a radio show on BlogtalkRadio and an online newsletter via paper.li.I have established Netiquette discussion groups with Linkedin and Yahoo. I am also a member of the International Business Etiquette and Protocol Group and Minding Manners among others. I regularly consult for the Gerson Lehrman Group, a worldwide network of subject matter experts and I have been contributing to the blogs Everything Email and emailmonday . My work has appeared in numerous publications and I have presented to groups such as The Breakfast Club of NJ and PSG of Mercer County, NJ.
Additionally, I am the president of Tabula Rosa Systems,
a “best of breed” reseller of products for communications, email,
network management software, security products and professional
services. Also, I am the president of Netiquette IQ. We are currently developing an email IQ rating system, Netiquette IQ, which promotes the fundamentals outlined in my book.
Over the past twenty-five years, I have enjoyed a dynamic and successful career and have attained an extensive background in IT and electronic communications by selling and marketing within the information technology market.
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