Medical Device Regulations Award (online course)

eduThis unit develops:

• Learners’ academic knowledge and critical awareness of the issues that comprise the Medical Device Regulations
• Understanding of how regulatory requirements affect business practice
• Applications to protect and sustain the company activities in their area of responsibility
• Determine appropriate compliance pathways, technical requirements and data
• Understanding of Quality Management Systems in relation to the Medical Device Directive

Assessment Criteria

As a professional qualification there are three key elements to be met:

• Technical Knowledge
• Regulatory Process Skills
• Reflective Practice

This unit will be assessed through three different activities:

• Candidates will complete a comprehensive written assessment which will include the regulatory principles applied to the risk management of the company commercial activity
• Candidates will complete a multiple-choice questionnaire covering all aspects of the taught Regulatory unit and it’s pre-course reading
• Candidates will be expected to demonstrate personal competencies in the business environment

Delivery

The programme will be delivered online with online assessment.

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