Medical Device Regulation 2017/745 EU regulatory affairs. free download

The objective of the course is to explain the medical device regulation 2017/745 in simple terms . The student will learn how to classify a medical device with examples, quizzes and guidance documents . This Course is broken into nine sections . The aim is to understand the European Union regulatory affairs for marketing a medical . device in the EU . The course will also provide an overview of how Switzerland, Turkey and the EFTA are affected by the MDR 2017 . The students will be able to choose a conformity assessment route for each particular classification of a . medical device . They will learn the requirements of post market surveillance (GSPR) and the requirements for a periodic safety update report .

What you’ll find out in Medical Device Policy 2017/745 EU regulative affairs.

  1. Understand European Union regulatory affairs for marketing a clinical tool in the EU.
  2. Why was there a modification from the regulation to the MDR 2017 745?
  3. The timelines for the shift of the MDR 2017 745.
  4. Economic Operators and their commitments. European Authorised Agent, Distributor, Importer, Maker and also procedure pack & & systems service providers.
  5. What is the obligation of an individual in charge of regulative conformity (PRRC)
  6. Recognize what EUDAMED is. What the Requirements are and transitional timelines. The actors enrollment.
  7. Distinct Tool Recognition and also registration. Exactly how a UDI service provider is produced. Authorised UDI suppliers as well as the timelines to package device with the UDI carrier.
  8. The student will certainly learn exactly how to identify a clinical device with instances, tests and also support files.
  9. The trainee will certainly learn exactly how to choose a consistency assessment route for each specific classification of a medical tool.
  10. Discover what is sufficient scientific data as well as exactly how to collect it. What is meant by desired purpose and also General Safety and security as well as efficiency Requirements. (GSPR)
  11. Find out the Requirements of blog post market monitoring. What a routine safety update record (PSUR) is. The trainee will certainly find out the Requirements of watchfulness.
  12. The pupil will certainly discover the function of the clinical device control team. MDCG
  13. Discover what typical specification and technical paperwork suggests.
  14. Understand the effects of Brexit on the MDR 2017/745.
  15. Understand just how Switzerland, Turkey and the EFTA are impacted by the MDR 2017/745.
  16. Understand what the EU payment rolling strategy is.

  • A wish to comprehend Clinical Tool Policy in straightforward terms


This Training course is burglarized nine sections. The purpose of the training course is to explain the medical tool policy 2017/745 in straightforward terms:
Area 1 Introduction.
Introduction to the Clinical device guideline 2017 745.
Why existed a modification from the instruction to the MDR 2017 745?

Section 2 Economic Driver.
Economic Operators. Who are they?
Economic Driver. The European Authorised representative. Explain their obligation.
Economic Driver. The Distributor. Explain their responsibility.
Economic Driver. The Importer. Discuss their obligation.

Economic Operator. The Treatment pack & & Solution Company. Explain their obligation.
When does a Financial operator commitment adjustment?
Discuss the responsibility of an individual responsible for regulative compliance
Intro to what EUDAMED is.

The timelines for the transition of EUDAMED system
Section 4 Special Gadget Recognition as well as registration
UDI Introduction Part 1. What is it? Why is it required?
UDI Part 2. Comprehend the special device recognition provider.
UDI Part 3. Understand that the current recognized organisations are that can create Distinct Gadget recognition provider Requirements.

Section 5 Category of clinical devices
Classification of clinical gadgets Intro.
Qualification of medical tools. Identify if the supplier is making a clinical tool.
Understand clinical device interpretations. This will assist the student exactly how to classify a medical device.

MDR apply clinical tool rules.
Area 6 Conformity analysis
Clarify the Conformity evaluation course for a Course I medical tool
Explain the consistency analysis course for a class I s, I m & & I r clinical tool.
Discuss the conformity analysis path for a Course II a clinical gadget.

Clarify the consistency assessment path for a Class III medical tool
Area 7 Sufficient Scientific data
The General Safety And Security and Performance Requirements.
The Planned objective.
Sufficient medical Information. Scientific Examination.
Message Market Medical Comply With up (PMCF).

Blog Post Market Security.
Post-market surveillance record & & Routine safety and security update.
Post-market caution.
Evaluation of alertness data.
Function of Competent Authority & & European Compensation within Market Monitoring
Section 9 Various Other Products

Swizterland Mutual Acknowledgment Agreement
Turkey and EFTA contract with the EU.
Common Requirements
The Moving strategy.
The advantages of the program will certainly be:
Conserve you time.
Really recognize law in simple terms.

Understand why guideline was presented.
Know your responsibility to the MDR 2017 745.
Know the obligation to EUDAMED and the timelines.
Examples of just how Distinct Tool Identification carriers are produced.
Worked instances how medical devices are classified.

Know what enough medical data to collect to be compliant.
Recognize the market security Requirements to permit the medical tool to stay in the marketplace place.
Understand the UK and EU suppliers responsibility article Brexit.
Understand Turkey as well as the EFTA (Switzerland, Liechtenstein, Norway as well as Iceland) manufacturers obligation relating to the MDR 2017 745.

Who this course is for:

  • Medical Device Engineers
  • Quality control within the medical device industry
  • Operation Managers within the medical device industry
  • Entrepreneurs or small medium start-up companies that need to develop a new medical device.
  • Quality Control Technicians
  • Process Engineers
  • Regulatory Affairs.
  • 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 auditors of the medical device Industry
  • Medical device manufacturers inside and outside of Europe.
  • Professionals engaged in ISO 13485 and Harmonised Standards within the European Union Market Place.
  • Small start companies who want to develop new products in the Medical device industry
  • Process and Development Engineers.
  • People managers within the Medical device and health care industry.
  • Manufacturing Engineers.
  • Students who need to really understand the medical device regulation 2017 745 in simple terms.
  • Health care providers. (Doctors and Nurses for example)
  • Professionals involved in pre clinical medical devices studies
  • Professionals involved in clinical trials of medical devices.
  • Professionals involved in Post market surveillance of medical devices.
  • Economic Operator The manufacturer.
  • Economic Operator The distributor.
  • Economic Operator The European Authorised Representative.
  • Economic Operator The Importer.
  • Economic Operator The Procedure Pack and Systems provider
File Name :Medical Device Regulation 2017/745 EU regulatory affairs. free download
Content Source:udemy
Genre / Category:Business
File Size :2.32 gb
Publisher :Martin Conneely
Updated and Published:03 Mar,2022
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File name: Medical-Device-Regulation-2017-745-EU-regulatory-affairs.rar
File Size:2.32 gb
Course duration:3 hours
Instructor Name:Martin Conneely
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