BSI’s Medical devices CE Marking course is designed to provide students with the knowledge to assist their companies in getting products to market more quickly. Internal and external auditors and management personnel responsible for quality systems for medical device manufacturers will benefit from this course. The students will gain knowledge of the Medical Device Directive and CE Marking approach to provide leadership for their organizations when placing medical devices on the market in the European Union.
Learning objectives
- Understand the structure of the Medical Devices Directive
- Understand EU classification of medical devices
- Establish an understanding of the European CE Marking approach
- Identify quality assurance requirements for medical devices sold to Europe
- Recognize the role of standards, essential requirements, and labeling
- Understand risk assessment
- Value post market surveillance and vigilance
- Upcoming changes to the MDD
Course materials
Students receive comprehensive course manuals with reference materials.
Who should attend
- Regulatory and quality staff responsible for preparing or hosting CE Marking audits
- Organizations new to the EU market with medical devices
- Those who need an understanding of the New European CE Marking approach for medical devices
- Personnel performing design and risk analysis for medical devices under development
- Companies preparing ‘own brand’ or ‘private labeling’ devices
Prerequisite
Participants should have experience with or basic knowledge of quality management systems for the medical device industry. A basic awareness of medical devices, quality assurance, and recognized standards (ISO 9000/ISO 13485) are also recommended.
