Our “Medical Devices CE Marking” three-day training course is designed to provide participants with the knowledge to assist their companies in getting products to market more quickly.
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 Benefits
- Get your products to market faster
- Gain a greater understanding of the European Directives
- Comply to directives efficiently and correctly
- Increase organizational awareness
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
Learning objectives
- 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
Next Steps
- Introduction to: ISO 13485 training course - Discover ISO 13485, it's importance and the links to the medical device directives. You'll look at comparisons between it's requirements and ISO 9001 and the Food and Drug Administration's Quality System Regulations
- Lead Auditor: ISO 13485 training course - Review ISO 13485 and build on the principles of process auditing in accordance with quality management system standards. Work with our training experts to understand the entire audit process at lead level from planning, to managing and reporting on audit results
- Medical Devices Risk Management: ISO 14971 training course - Our ISO 14971 risk management training is an essential element for all medical device manufacturers. You will learn how to identify, evaluate and control risks associated with medical devices throughout the product lifecycle, helping you implement a risk management framework to achieve ongoing compliance.
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