TypeOnline Course
Price$180 / Rs. 8500
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Introduction:

NCK’s “Medical Devices CE Marking” 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.

Learning Objectives:

On completion of training, participants will be able to:

  • Explain the European CE Marking approach and its legal and operational requirements
  • Explain the structure and purpose of the medical devices directive
  • 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 personnels handling medical devices
  • Organizations preparing ‘own branding’ or ‘private labelling’ of devices
  • Potential internal auditors and others who need an in-depth knowledge of the requirements of the medical devices directives.

Duration: 1 Month

How will I learn?

In this online self-paced modules, participant will be understanding in detail about the CE marking – operational basics to regulatory processing details.

Course Deliverable: 

  • Upon admission you will be providing the user id and password to access all the content online.
  • You will also be receiving the soft copy of the e-module (which you can download from your dashboard).

 

Section 1General Understanding on CE marking?
Lecture 1Introduction: CE Marking
Lecture 2CE - Self Certification
Lecture 3What CE marking provides?
Lecture 4General Principles of CE marking?
Lecture 5Where CE marking Required?
Lecture 6Manufacturer's Responsibility
Lecture 7Third Party Medical Device Manufacturing & CE Marking
Lecture 8Classification of Medical Devices: Based on Manufacturing Capabilities
Lecture 9OBL/PBL/PLM/OEM/OES - Case Study
Section 2Step By Step: CE Marking Processing
Lecture 10Step 1
Lecture 11Step 2
Lecture 12Step 3
Lecture 13Step 4
Lecture 14Step 5
Lecture 15Step 6
Lecture 16CE Marking Process Flow
Section 3Medical Devies Different Classes - CE Marking Step by step
Lecture 17EU classification of Medical Devices
Lecture 18Quality System By CE Class
Lecture 19Pathway of CE Marking for Class I Medical Devices
Lecture 20Pathway of CE Marking for Class IIa Medical Devices
Lecture 21Pathway of CE Marking for Class IIb Medical Devices
Lecture 22Pathway of CE Marking for Class III Medical Devices
Section 4Technical Record/Dossier for CE Marking
Lecture 23Introduction: Techical Documentation
Lecture 24Compoents of Techincal Documentation
Lecture 25Techical Documents - Information Required
Section 5Case Analysis
Lecture 26CASE 1
Lecture 27CASE 2
Lecture 28CASE 3