Our Introduction to CE Marking training course will give you a solid understanding of the medical devices regulatory requirements and directives to help you sell your products within the EU. You will gain an introduction to the Medical Device Directives and understand their background and key features.
Find ways to reduce the risks and uncertainty in the EU regulatory process and thus bring products to the EU market more quickly. Get started today with our awareness course.
CE Marking is a legal requirement for medical devices intended for sale in Europe. They are three European CE Marking directives that specifically apply to medical devices manufacturers: the Medical Devices Directive (MDD), the Active Implantable Medical Devices Directive (AIMDD) and the In Vitro Diagnostics Directive (IVDD). Our expert trainers will help you understand and meet these directives to ensure your product completes the CE Marking process efficiently and successfully.
Course Benefits
- Make informed decisions on meeting the requirements of medical device directives
- Identify the steps required to reduce the risks in the regulatory process and bring your product to the EU market much quicker
- Identify the necessary steps required for post market surveillance and for reporting adverse incidents under the vigilance system
Who should attend?
- Those working in regulatory, design, development, manufacturing or marketing roles
- Internal auditors or those planning to become internal auditors
- Those who need in-depth knowledge of medical devices directives
- Organisations preparing own branding or private labelling
Learning objectives
- Understand the role of essential requirements as the basis for the CE Marking
- Use of standards and the role of clinical data and risk management
- Understand the European CE Marking approach with respect to medical devices
- The role of active implantables and In Vitro Diagnostics (IVDs)
- Significance of the EU risk classification criteria for medical devices
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.
