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.

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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.