Medical Devices: Regulation and Lifecycle Management 2015 is a course that covers topics such as:
- EU Medical device regulation: philosophy, content and structure Directive 93/42/EC, as amended by 2007/47/EC CE mark ISO 14155, ISO 13485 and ISO 14791 Risk-classification of medical devices Drug-device combination products Clinical evaluation and clinical investigation Medical devices vigilance system Recent and upcoming legal changes in Europe
Medical Devices: Regulation and Lifecycle Management 2015 brings together:
- Regulatory bodies who would like to get acquainted quickly with all aspects of medical device regulation
- Professionals starting work in industry
- Professionals in pharmaceuticals