Medical Devices CE Marking Training

Course details

Who should attend?

Regulatory, quality, design, development, manufacturing, marketing managers and personnel
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
What will I learn?

On completion of this training, participants will be able to:
Explain the European CE Marking approach and its legal and operational basis
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 labelling 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
What are the benefits?

Benefit from CE Marking expertise within your organisation
Work without uncertainty when placing products on the EU market
Gain recognition as a producer of products with CE Marking
Improve the quality and safety of your medical devices
Increase EU market access and boost customer confidence
What is included?

Training course notes
Lunch
Refreshments
Certificate of attendance