Medical Devices CE Marking Deep Dive Training Course
This course will teach you how to start making informed decisions with regards to meeting the requirements of the EU Medical Devices Directives. On completion of the training, participants will be able to identify the steps required to reduce the risks and uncertainty in the EU regulatory process and thus save time bringing products to the EU market.
Who should attend?
- Regulatory, quality, design, development, manufacturing, marketing managers
- Virtual manufacturers
- Potential internal auditors and others who need an in-depth knowledge of the requirements of the medical devices directives
- All personnel who need to understand the medical device regulation requirements
What will I learn?
Upon completion of this training, delegates will be able to:
- Explain the European CE marking approach
- 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 manufacture’s regulatory responsibilities, including reporting of changes to products and QMS system to the notified Body
- Identify the relevance of recent changes to the medical devices directives
- Conduct internal and external audits for compliance with the directives
How will I benefit?
- Benefit from CE Marking expertise within your organization
- 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
This training course is HRDF approved under the SBL scheme.
On completion, you will be awarded an internationally recognized BSI Training Academy certificate.