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).
