EU Medical Device Regulatory Affairs explained Simply
EU Medical Device Regulatory Affairs explained Simply, available at $74.99, has an average rating of 4.55, with 16 lectures, 11 quizzes, based on 431 reviews, and has 1257 subscribers.
You will learn about Understand how Medical Device Regulation works in the European Union. Differentiate between a regulation and a directive. Steps required to gain permission to manufacture and sell a medical device in the European Union. Explain the roles and responsibilities of a Competent Authority & a Notified Body with regard to European Union regulation. Understand in simple terms the Active Implantable Medical Device Directive 90/385/EEC. Understand in simple terms the Medical Device Directive 93/42/EEC. Understand in simple terms the In Vitro Diagnostic Medical Device directive 98/79/EEC Understand the difference between the directives and the new Medical Device Regulation, MDR EU 2017/745(MDR) & EU 2017/746 (IVDR). How to obtain CE Marking. Classification of medical devices in the European Union. What part does ISO 13485 2016 play in the European Union regulation system. Understand the part that Manufacturer, the Authorized representative and the EFTA play in the European Union regulation system. Brexit understand the impact to the European Union regulation. Understand the transitional time lines from the directives to the medical device regulation. Understand regulatory affairs This course is ideal for individuals who are Medical Device Engineers or Quality control within the medical device industry or Operation Managers within the medical device industry or Entrepreneurs in setting up medical device technologies. or Quality Control Technicians or Process Engineers or Quality Control Engineers or Regulation or Marketing within the medical device industry. or Research and Development Engineers within the Medical device industry or Students in Biomechanical Engineering. or Students in Pharmaceutical science. or Students in Regulation affairs. or Students in Quality Assurance and quality control. or Internal and external audits of the medical device Industry or Medical device manufacturers inside and outside of Europe. It is particularly useful for Medical Device Engineers or Quality control within the medical device industry or Operation Managers within the medical device industry or Entrepreneurs in setting up medical device technologies. or Quality Control Technicians or Process Engineers or Quality Control Engineers or Regulation or Marketing within the medical device industry. or Research and Development Engineers within the Medical device industry or Students in Biomechanical Engineering. or Students in Pharmaceutical science. or Students in Regulation affairs. or Students in Quality Assurance and quality control. or Internal and external audits of the medical device Industry or Medical device manufacturers inside and outside of Europe.
Enroll now: EU Medical Device Regulatory Affairs explained Simply
Summary
Title: EU Medical Device Regulatory Affairs explained Simply
Price: $74.99
Average Rating: 4.55
Number of Lectures: 16
Number of Quizzes: 11
Number of Published Lectures: 16
Number of Published Quizzes: 11
Number of Curriculum Items: 27
Number of Published Curriculum Objects: 27
Original Price: $199.99
Quality Status: approved
Status: Live
What You Will Learn
- Understand how Medical Device Regulation works in the European Union.
- Differentiate between a regulation and a directive.
- Steps required to gain permission to manufacture and sell a medical device in the European Union.
- Explain the roles and responsibilities of a Competent Authority & a Notified Body with regard to European Union regulation.
- Understand in simple terms the Active Implantable Medical Device Directive 90/385/EEC.
- Understand in simple terms the Medical Device Directive 93/42/EEC.
- Understand in simple terms the In Vitro Diagnostic Medical Device directive 98/79/EEC
- Understand the difference between the directives and the new Medical Device Regulation, MDR EU 2017/745(MDR) & EU 2017/746 (IVDR).
- How to obtain CE Marking.
- Classification of medical devices in the European Union.
- What part does ISO 13485 2016 play in the European Union regulation system.
- Understand the part that Manufacturer, the Authorized representative and the EFTA play in the European Union regulation system.
- Brexit understand the impact to the European Union regulation.
- Understand the transitional time lines from the directives to the medical device regulation.
- Understand regulatory affairs
Who Should Attend
- Medical Device Engineers
- Quality control within the medical device industry
- Operation Managers within the medical device industry
- Entrepreneurs in setting up medical device technologies.
- Quality Control Technicians
- Process Engineers
- Quality Control Engineers
- Regulation
- Marketing within the medical device industry.
- Research and Development Engineers within the Medical device industry
- Students in Biomechanical Engineering.
- Students in Pharmaceutical science.
- Students in Regulation affairs.
- Students in Quality Assurance and quality control.
- Internal and external audits of the medical device Industry
- Medical device manufacturers inside and outside of Europe.
Target Audiences
- Medical Device Engineers
- Quality control within the medical device industry
- Operation Managers within the medical device industry
- Entrepreneurs in setting up medical device technologies.
- Quality Control Technicians
- Process Engineers
- Quality Control Engineers
- Regulation
- Marketing within the medical device industry.
- Research and Development Engineers within the Medical device industry
- Students in Biomechanical Engineering.
- Students in Pharmaceutical science.
- Students in Regulation affairs.
- Students in Quality Assurance and quality control.
- Internal and external audits of the medical device Industry
- Medical device manufacturers inside and outside of Europe.
Each lecture is explained in simple format. If the student takes each lecture step by step, they will understand how a company gains permission to manufacture a medical device which will be allowed to be sold in Europe. 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. If you are a student who wants to understand the rules that govern the sale of medical devices in the European Union Market place this course is perfect for you. If you are a medical device manufacturer outside the European Union and would like to sell your product in Europe this course is ideal for you. You will understand how important the ISO 13485 2016 standard is to gain market approval.
The following topics will be covered:
-
´Difference between Regulation and a Directive.
-
´Steps required to get permission to manufacture and sell a medical device in Europe.
-
´Competent authority
-
´Notified body.
-
´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 .
-
´MDR EU 2017/745(MDR) & EU 2017/746 (IVDR).
-
´CE Marking approval process.
-
´Classification of medical device. Including the MDR 2017 745 classification.
-
´ISO 13485 2016
-
´Other players the Manufacturer, the Authorized representative and the EFTA.
Each lecture has a quiz that will enable students to understand the learner outcomes
-
Brexit understand the impact to the European Union regulation.
-
Understand the transitional time lines from the directives to the medical device regulation.
Course Curriculum
Chapter 1: Introduction
Lecture 1: Review
Lecture 2: Introduction
Lecture 3: Lecture: 93/42/EEC
Lecture 4: Lecture: 98/79/EEC
Lecture 5: Lecture: 90/385/EEC
Lecture 6: Lecture: MDR 2017/745 & 2017/746
Lecture 7: Definition of Medical device MDR 2017/745
Lecture 8: Lecture 5 Competent Authority
Lecture 9: lecture: Notified Body
Lecture 10: Lecture: Medical Device Classification
Lecture 11: MDR 2017/745 Classification Rule
Lecture 12: Lecture:Other Players (Authorized Representative, Manufacturer and EFTA)
Lecture 13: Lecture 9: ISO 13485
Lecture 14: Lecture: 5 Steps to Medical Device Regulation in Europe
Lecture 15: Brexit
Lecture 16: PDF Document of lecture notes.
Instructors
-
Martin Conneely
Academic
Rating Distribution
- 1 stars: 3 votes
- 2 stars: 10 votes
- 3 stars: 66 votes
- 4 stars: 173 votes
- 5 stars: 179 votes
Frequently Asked Questions
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