Medical Device Regulation 2017/745 EU regulatory affairs.

Medical Device Regulation 2017/745 EU regulatory affairs., available at $69.99, has an average rating of 4.43, with 53 lectures, 41 quizzes, based on 1198 reviews, and has 3843 subscribers.

You will learn about Understand European Union regulatory affairs for marketing a medical device in the EU. Why was there a change from the directive to the MDR 2017 745? The timelines for the transition of the MDR 2017 745. Economic Operators and their obligations. European Authorised Representative, Distributor, Importer, Manufacturer and procedure pack & systems providers. What is the obligation of a person responsible for regulatory compliance (PRRC) Understand what EUDAMED is. What the requirements are and transitional timelines. The actors registration. Unique Device Identification and registration. How a UDI carrier is created. Authorised UDI providers and the timelines to package device with the UDI carrier. The student will learn how to classify a medical device with examples, quizzes and guidance documents. The student will learn how to choose a conformity assessment route for each particular classification of a medical device. Learn what is sufficient clinical data and how to collect it. What is meant by intended purpose and General Safety and performance requirements. (GSPR) Learn the requirements of post market surveillance. What a periodic safety update report (PSUR) is. The student will learn the requirements of vigilance. The student will learn the role of the medical device coordination group. MDCG Learn what common specification and technical documentation means. Understand the implications of Brexit on the MDR 2017/745. Understand how Switzerland, Turkey and the EFTA are affected by the MDR 2017/745. Understand what the EU commission rolling plan is. The MDR 2017/745 will help the student how to be compliant to ISO 13485 and a Quality Management System for a medical device manufacturer. 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 or small medium start-up companies that need to develop a new medical device. or Quality Control Technicians or Process Engineers or Regulatory Affairs. 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 auditors of the medical device Industry or Medical device manufacturers inside and outside of Europe. or Professionals engaged in ISO 13485 and Harmonised Standards within the European Union Market Place. or Small start companies who want to develop new products in the Medical device industry or Process and Development Engineers. or People managers within the Medical device and health care industry. or Manufacturing Engineers. or Students who need to really understand the medical device regulation 2017 745 in simple terms. or Health care providers. (Doctors and Nurses for example) or Professionals involved in pre clinical medical devices studies or Professionals involved in clinical trials of medical devices. or Professionals involved in Post market surveillance of medical devices. or Economic Operator The manufacturer. or Economic Operator The distributor. or Economic Operator The European Authorised Representative. or Economic Operator The Importer. or Economic Operator The Procedure Pack and Systems provider 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 or small medium start-up companies that need to develop a new medical device. or Quality Control Technicians or Process Engineers or Regulatory Affairs. 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 auditors of the medical device Industry or Medical device manufacturers inside and outside of Europe. or Professionals engaged in ISO 13485 and Harmonised Standards within the European Union Market Place. or Small start companies who want to develop new products in the Medical device industry or Process and Development Engineers. or People managers within the Medical device and health care industry. or Manufacturing Engineers. or Students who need to really understand the medical device regulation 2017 745 in simple terms. or Health care providers. (Doctors and Nurses for example) or Professionals involved in pre clinical medical devices studies or Professionals involved in clinical trials of medical devices. or Professionals involved in Post market surveillance of medical devices. or Economic Operator The manufacturer. or Economic Operator The distributor. or Economic Operator The European Authorised Representative. or Economic Operator The Importer. or Economic Operator The Procedure Pack and Systems provider.

Enroll now: Medical Device Regulation 2017/745 EU regulatory affairs.

Summary

Title: Medical Device Regulation 2017/745 EU regulatory affairs.

Price: $69.99

Average Rating: 4.43

Number of Lectures: 53

Number of Quizzes: 41

Number of Published Lectures: 53

Number of Published Quizzes: 41

Number of Curriculum Items: 94

Number of Published Curriculum Objects: 94

Original Price: $199.99

Quality Status: approved

Status: Live

What You Will Learn

Understand European Union regulatory affairs for marketing a medical device in the EU.
Why was there a change from the directive to the MDR 2017 745?
The timelines for the transition of the MDR 2017 745.
Economic Operators and their obligations. European Authorised Representative, Distributor, Importer, Manufacturer and procedure pack & systems providers.
What is the obligation of a person responsible for regulatory compliance (PRRC)
Understand what EUDAMED is. What the requirements are and transitional timelines. The actors registration.
Unique Device Identification and registration. How a UDI carrier is created. Authorised UDI providers and the timelines to package device with the UDI carrier.
The student will learn how to classify a medical device with examples, quizzes and guidance documents.
The student will learn how to choose a conformity assessment route for each particular classification of a medical device.
Learn what is sufficient clinical data and how to collect it. What is meant by intended purpose and General Safety and performance requirements. (GSPR)
Learn the requirements of post market surveillance. What a periodic safety update report (PSUR) is. The student will learn the requirements of vigilance.
The student will learn the role of the medical device coordination group. MDCG
Learn what common specification and technical documentation means.
Understand the implications of Brexit on the MDR 2017/745.
Understand how Switzerland, Turkey and the EFTA are affected by the MDR 2017/745.
Understand what the EU commission rolling plan is.
The MDR 2017/745 will help the student how to be compliant to ISO 13485 and a Quality Management System for a medical device manufacturer.

Who Should Attend

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

Target Audiences

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

This Course is broken into nine sections. The objective of the course is to explain the medical device regulation 2017/745 in simple terms:

Section 1 Introduction.

Introduction to the Medical device regulation 2017 745.

Why was there a change from the directive to the MDR 2017 745?

The timelines for the transition of the MDR 2017 745. How the COVID pandemic has impact these timelines

Section 2 Economic Operator.

Economic Operators. Who are they?

Economic Operator. The European Authorised representative. Explain their obligation.

Economic Operator. The Distributor. Explain their obligation.

Economic Operator. The Importer. Explain their obligation.

Economic Operator. The Manufacturer. Explain their obligation.

Economic Operator. The Procedure pack & Systems Provider. Explain their obligation.

When does an Economic operator obligation change?

Explain the obligation of a person responsible for regulatory compliance

Section 3 EUDAMED

Introduction to what EUDAMED is.

Understand what is meant by the actor registration.

The timelines for the transition of EUDAMED system

Section 4 Unique Device Identification and registration

UDI Introduction Part 1. What is it? Why is it needed?

UDI Part 2. Understand the unique device identification carrier.

UDI Part 3. Understand who the current accredited organisations are that can create Unique Device identification carrier standards.

UDI timelines. When the UDI carrier needs to be attached to the packaging and devices.

Section 5 Classification of medical devices

Classification of medical devices Introduction.

Qualification of medical devices. Determine if the manufacturer is making a medical device.

Understand medical device definitions. This will help the student how to classify a medical device.

Rules of medical device classification. Understand the implementation of the rules.

MDR apply medical device rules.

Section 6 Conformity assessment

Explain the Conformity assessment path for a Class I medical device

Explain the conformity assessment path for a class I s, I m & I r medical device.

Explain the conformity assessment path for a Class II a medical device.

Explain the conformity assessment path for a Class II b medical device.

Explain the conformity assessment path for a Class III medical device

Section 7 Sufficient Clinical data

The General Safety and Performance Requirements.

The Intended purpose.

Sufficient clinical Data. Clinical Evaluation.

Post Market Clinical Follow up (PMCF).

Section 8 Post Market Surveillance.

Post Market Surveillance.

Post-market surveillance report & Periodic safety update.

Post-market vigilance.

Analysis of vigilance data.

Role of Competent Authority & European Commission within Market Surveillance

Section 9 Other Items

Medical device coordination group

Brexit

Swizterland Mutual Recognition Agreement

Turkey and EFTA agreement with the EU.

Common Specifications

The Rolling plan.

The benefits of the course will be:

Save you time.

Really understand regulation in simple terms.

Help you prioritizes work to prepare for the MDR 2017 745 timelines.

Understand why regulation was introduced.

Know your obligation to the MDR 2017 745.

Know the obligation to EUDAMED and the timelines.

Examples of how Unique Device Identification carriers are created.

Worked examples how medical devices are classified.

Know the conformity assessment route to take for each medical device.

Know what sufficient clinical data to collect to be compliant.

Understand the market surveillance requirements to allow the medical device to stay in the market place.

Understand the UK and EU manufacturers responsibility post Brexit.

Understand Turkey and the EFTA (Switzerland, Liechtenstein, Norway and Iceland) manufacturers responsibility regarding the MDR 2017 745.

Course Curriculum

Chapter 1: Section 1 Introduction

Lecture 1: Section 1 Introduction

Lecture 2: Introduction

Lecture 3: Why change?

Lecture 4: Timelines

Chapter 2: Section 2 Economic Operators

Lecture 1: Section 2 Economic Operators

Lecture 2: Economic Operators

Lecture 3: Economic Operator: The European Authorised Representative.

Lecture 4: Economic Operator: The Distributor

Lecture 5: Economic Operator: The importer

Lecture 6: Economic Operator: The manufacturer

Lecture 7: Economic Operator: Procedure pack & Systems Provider

Lecture 8: Economic Operator: Obligation change

Lecture 9: Person Responsible for Regulatory Compliance

Chapter 3: Section 3 EUDAMED

Lecture 1: Section 3 EUDAMED

Lecture 2: EUDAMED Introduction

Lecture 3: EUDAMED Actors registration

Lecture 4: EUDAMED Timelines

Chapter 4: Section 4 UDI/Registration

Lecture 1: Section 4 UDI/Registration

Lecture 2: UDI Part 1 Introduction

Lecture 3: UDI Part 2

Lecture 4: UDI Part 3

Lecture 5: UDI Timelines

Chapter 5: Section 5 Classification of medical devices

Lecture 1: Section 5 Classification of medical devices

Lecture 2: Classification of medical devices Introduction

Lecture 3: Qualification of a medical device

Lecture 4: Medical device definitions

Lecture 5: Medical device classification rules

Lecture 6: Apply Medical Device Rules

Chapter 6: Section 6 Conformity assessment

Lecture 1: Section 6 Conformity assessment

Lecture 2: MDR Class I Conformity Assessment Route

Lecture 3: MDR Class I r, Class I m, Class I r and Class II a conformity Assessment

Lecture 4: MDR Class II a conformity assessment route

Lecture 5: MDR Class II b conformity assessment route

Lecture 6: MDR Class III conformity assessment route

Chapter 7: Section 7 Sufficient Clinical Data

Lecture 1: Section 7 Sufficient Clinical Data

Lecture 2: General safety and performance requirement

Lecture 3: Intended Purpose

Lecture 4: Sufficient Clinical Data. Clinical Evaluation

Lecture 5: Sufficient clinical Data. Post market clinical follow up.

Chapter 8: Section 8 Post market Surveillance

Lecture 1: Section 8 Post Market Surveillance

Lecture 2: Post market surveillance system & plan.

Lecture 3: Post market surveillance report and Periodic safety update report

Lecture 4: Vigilance system

Lecture 5: Analysis of vigilance data

Lecture 6: Role of Competent Authority & European Commission within Market Surveillance

Chapter 9: Section 9 Miscellaneous

Lecture 1: Section 9 Miscellaneous

Lecture 2: Medical Device Coordination Group "Guidelines"

Lecture 3: Brexit

Lecture 4: Switzerland Mutual Recognition Agreement

Lecture 5: Turkey & EFTA MDR 2017 745

Lecture 6: Common Specifications

Instructors

Martin Conneely
Academic

Rating Distribution

1 stars: 8 votes
2 stars: 18 votes
3 stars: 126 votes
4 stars: 479 votes
5 stars: 567 votes

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