This qualification will create Regulatory Medical Device professionals equipped with the technical knowledge, implementation skills and professional attitudes to deliver the highest standards of Healthcare Compliance in the Medical Devices sector of Life Sciences. The Medical Device Regulations and the laws will be studied in relation to how they are applied.
The Diploma is for Regulatory Professionals already involved in the legal aspects of medical device design, manufacture, sales and marketing. They will understand the basic tenet of medical devices directive and compliance with the local regulations in day to day commerce.
The assessment process has been designed to ensure that each assessment criterion covers the full range of issues taught on the programme. Under exam conditions candidates are required to demonstrate their knowledge of the issues, interpret that knowledge in reflective practice exercises and demonstrate how to apply the knowledge and skills in a product development and approvals environment.
The programme will be delivered as a combination of online, 4 days fully taught classroom training with pre-course reading and online assessment.
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