HC Skills InternationalHC Skills International

Medical Device Regulations Award (online course)

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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


The programme will be delivered online with online assessment.

For more information about qualifications across the United Kingdom and Ireland click here.

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