EU Medical Device Regulatory Affairs explained Simply
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EU Medical Device Regulatory Affairs explained Simply at UDEMY Overview
EU Medical Device Regulatory Affairs explained Simply
at UDEMY
Understand regulatory affairs & ISO 13485 2016
Duration | 3 hours |
Total fee | ₹455 |
Mode of learning | Online |
Credential | Certificate |
EU Medical Device Regulatory Affairs explained Simply at UDEMY Highlights
EU Medical Device Regulatory Affairs explained Simply
at UDEMY
- Earn a Certificate of completion from Udemy
- 30-Day Money-Back Guarantee
- Full lifetime access
- Access on mobile and TV
- 3 downloadable resources
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EU Medical Device Regulatory Affairs explained Simply at UDEMY Course details
EU Medical Device Regulatory Affairs explained Simply
at UDEMY
Skills you will learn
Who should do this course?
- For Medical Device Engineers
What are the course deliverables?
- Difference between Regulation and a Directive
- Steps required to get permission to manufacture and sell a medical device in Europe
- MDD 90/385/EEC Active Implantable Medical Device Directive.
- MDD 93/42/EEC Medical Device Directive.
- MDD 98/79/EEC The directive of In Vitro Diagnostic Medical Devices
- Classification of medical device. Including the MDR 2017 745 classification
More about this course
- This module is ideal for a person who wants to work in medical device regulation, who wants to be involved in a medical device start up or who wants to be involved in the medical device industry either in operations, quality, engineering, marketing and research/development
- You will understand how important the ISO 13485 2016 standard is to gain market approval
EU Medical Device Regulatory Affairs explained Simply at UDEMY Curriculum
EU Medical Device Regulatory Affairs explained Simply
at UDEMY
Introduction
Introduction
Lecture: 93/42/EEC
Lecture: 98/79/EEC
Lecture: 90/385/EEC
Lecture: MDR 2017/745 & 2017/746
Definition of Medical device MDR 2017/745
Lecture 5 Competent Authority
lecture: Notified Body
Lecture: Medical Device Classification
MDR 2017/745 Classification Rule
Lecture:Other Players (Authorized Representative, Manufacturer and EFTA)
Lecture 9: ISO 13485
Lecture: 5 Steps to Medical Device Regulation in Europe
EU Medical Device Regulatory Affairs explained Simply at UDEMY Faculty details
EU Medical Device Regulatory Affairs explained Simply
at UDEMY
Martin Conneely
20 years experience working in high volume manufacturing. He has worked in the semiconductor business for 10 years
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