InstructorRoyed Training
TypeOnline Course
Student Enrolled1
Price$180 USD / 9900 INR.
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CE certification for Medical Device

Introduction

Learning Objective

Who should attend

Related Courses

medical devices CE certification training

Royed’s “Fundamental Training on CE certification in Medical Devices” short certificate course is designed to provide participants with the knowledge to assist their companies in getting products to adhere to CE marking needs and necessities. Management personnel responsible for all aspects of CE marking medical devices as well as internal and external auditors will benefit from this course. Participants will gain knowledge of the requirements of the Medical Device Directive and the CE Marking approach. Participants will be able to provide leadership for their organizations when placing medical devices on the market in the European Union.

  • Course Code: RYD-035
  • Title of the course: CE Certification in Medical Devices
  • Nature of the course: Microlearning, online distance learning course. It is self paced learning course. Therefore the course can be accessed online across anywhere 24×7.
  • Duration of the course : 3 Days
  • Course Certificate : Certificate will be provided at the end of the successful completion of the course.

Learning Objectives:

On completion of training, participants will be able to:

  • European CE Marking approach and its legal and operational requirements.
  • Understanding of EU Medical Device Regulation.
  • Implement the EU risk classification criteria for medical devices
  • Identify the conformity assessment routes and quality assurance requirements for the various risk classes
  • Describe the role of the essential requirements as the basis for CE Marking, including the use of standards
  • Explain the importance and role of clinical data
  • List labeling requirements
  • Identify the regulatory significance of risk management and process validation
  • Identify the necessary steps required for post market surveillance for different risk classes
  • Interpret the criteria for reporting adverse incidents under the vigilance system
  • Define the manufacturer’s regulatory responsibilities, including reporting of changes to products and QMS system to the Notified Body
  • Identify technical documentation requirements
  • Identify the relevance of recent changes to the medical device directives
  • Conduct internal and external audits for compliance with the directives

Who Should Attend:

  • Regulatory, quality, design, development, manufacturing, marketing managers and personnel handling medical devices
  • Organizations preparing ‘own branding’ or ‘private labeling’ of devices
  • Potential internal auditors and others who need an in-depth knowledge of the requirements of the medical devices directives.
Section 1Learning Session [Lectures, Simulation, Self Assessment]
Lecture 1EU MDR Classification
Lecture 2EU MDD | EU MDR | Articles | Rules | Pages | Annex | Key Changes in EU MDR
Lecture 3EU MDR  | Annexes | Key notes
Lecture 4EU Medical Device Regulation System | MDR | IVDR | UDI | EUDAMED | Requirements for manufacturer | Importer | Distributor | Declaration of Conformity (DoC)
Lecture 5EU MDR Guideline | EU MDR - Annexes 
Lecture 6EU MDR Conformity Assessment procedure | Assessment of various classes and types of the devices | Key points to consider | Conformity assessment master chart 
Section 2CE Marking Process
Lecture 7CE Marking | Introduction | Self Certification | General principles of the CE marking | Manufacturer Responsibilities | Third Party Medical Device Manufacturing & CE Marking | Step By Step CE Marking Process
Lecture 8CE- Self Certification
Lecture 9General principles of the CE marking
Lecture 10Manufacturer Responsibilities
Lecture 11Third Party Medical Device Manufacturing & CE Marking
Lecture 12Understanding Terminologies - OBL/PBL/PLM/OEM/OES
Lecture 13Case Study