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Medical device 1

Question 1

QuestionAnswer
Tell me about Irelands MedTech Sector Grown from 50 to 350 companies since 1990 Largest employer of MedTech professionals in Europe (per capita) 12.6 billion export per year up 48% from 2017 38,000 employed in Ireland (50% RandD)
What is contributing to the success of the MedTech sector in Ireland? Advancing technology for an aging population Industrial Supports-IDA(encourages investment in Ireland, provides consultancy)-Irish Government (Grants Taxation )-IBEC (Irelands biggest business representative group)-Enterprise (Funding for start up&ed)
What has Medtech done for education in Ireland 16 centres based in ATU including MET
Roles Played by Biomedical Engineers. Clinical Engineer (Understands biological solution) Design Engineer Research Scientist (RANDD)
Roles Played by Biomedical Engineers. Clinical Engineer (Understands biological solution) Design Engineer Research Scientist (RANDD)
What is a medical device Medical devices: Tool that provides a medical purpose trough mechanical, magnetic or physical means. From diagnostic to prosthetic etc
What is a medical device Medical devices: Tool that provides a medical purpose trough mechanical, magnetic or physical means. From diagnostic to prosthetic etc
Why are Regulatory affairs important for medical devices Legal obligation. Prove it is safe in EU and US. Important to get device on Market
Tell me about the testing process for a medical device Think ahead to what kind of tests need to be ran Testing has to demonstrate safety Lab testing, Animal testing, Clinical testing
Tell me about the testing process for a medical device Think ahead to what kind of tests need to be ran Testing has to demonstrate safety Lab testing, Animal testing, Clinical testing
Medical Device Approval Pathways CE Mark: High safety and health and environment. Less powerful FDA: US - Device is safe and effective. Longer but more affective Device classification: Based on risk level class 1 to class 3.
FDA Regulates more then 2.6 trillion products of 6500 categories. (4000 device application/year)
Difference between a drug and a medical device. Device uses mechanical, magnetic or physical means drugs use chemical
What are the catagoreis for medical devices 1, Non Contact Devices 2. Surface-contacting devices 3. External communicating devices 3. Implant devices
What is a Good design principle for a medical device Clinical need
Difference between anatomy and Physiology Anatomy - Study of structure of body Physiology- How the structures act
Created by: noreenkennedy
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