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Medical Device Regulations Certificate (Level 6)

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 aim of the Certificate in Medical Devices is to develop academic knowledge and critical awareness of the issues which comprise the Medical Device Regulations, and to develop their understanding of how commercial ventures may give rise to legal issues
  • The regulations and laws will be studied in relation to how they are applied

Assessment Criteria

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 apply the knowledge and skills in a product development and approvals environment.

  • Verbal Technical Instruction Exercise
    Candidates will complete verbal technical instruction assessment exercises providing reasoned arguments for decisions
  • Risk Management Written Exercise
    Candidates will complete a written exercise demonstrating a Quality Management system for the safe use and compliance of medical devices
  • Short Assignment
    Candidates will prepare a report for Verification, Validation and Post Market Surveillance of Medical Devices
  • Multiple Choice Question Paper
    Candidates will complete a multiple-choice questionnaire covering all aspects of the taught units and the relevant pre-course reading personal competencies in an actual business environment

Delivery

The programme will be delivered as a combination of online and three days fully taught classroom training with pre-course reading and online assessment.

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