Pearson
Level 4
QN: 610/6104/9
Curriculum Active
Pearson BTEC Level 4 Higher National Certificate in MedTech for England
Official qualification regulated by Ofqual, awarded by Pearson. Classified as a Other Vocational Qualification. Total guided learning hours: 480 hours.
Qualification Level
Level 4
Awarding Body
Pearson
Syllabus Units
8 Units
Guided Hours
480 hrs
Instant access to interactive lessons, quizzes, and spaced revision.
Course Syllabus & Study Modules
Complete breakdown of verified curriculum topics and learning objectives.
1
Applied Programming
Verified
Key Learning Objectives:
- Explore the fundamentals of programming.2.
- Review the principles and components of event-driven programming.3.
- Demonstrate an understanding of Object-Orientated Programming (OOP).4.
- Develop a programmed solution for an identified medical application.
2
Designing a MedTech Project (Pearson Set)
Verified
Key Learning Objectives:
- Conduct small-scale research in relation to a given MedTech project brief.2.
- Develop a design based on the requirements of a given MedTech project brief.3. Present the design recommendations to an intended audience.4. Refine the design based on stakeholder feedback.
3
Introduction to MedTech
Verified
Key Learning Objectives:
- Review the MedTech sector and the progression opportunities within it.2.
- Explain the key terms, concepts and categories in MedTech design, manufacture and utilisation.3.
- Explore the impact of medical technology on clinical and preventive healthcare settings.4.
- Review the data management regulations and requirements in the MedTech industry.
4
Medical Devices
Verified
Key Learning Objectives:
- Review the different types of classification used for medical devices.2.
- Explore the stages of the product life cycle for medical devices.3.
- Explain the different technology readiness levels (TRLs) as applied to medical devices.4. Present an investigation of an identified medical device to an intended audience.
5
Quality Management Systems (ISO 13485)
Verified
Key Learning Objectives:
- Review the rationale for introducing ISO standards into the MedTech sector.2.
- Discuss the essential features of the ISO 13485 standard used in the MedTech sector.3.
- Explore the benefits and challenges to an organisation implementing the ISO 13485 standard within the MedTech sector.4.
- Explain how the ISO 13485 standard can be applied to a given MedTech scenario.
6
Regulatory Compliance
Verified
Key Learning Objectives:
- Explain the core concepts and terminology of MedTech regulations.2.
- Review the key regulatory frameworks that cover MedTech applications.3.
- Discuss the rationale behind regulation compliance and standard operating procedures (SOPs).4.
- Develop a regulatory-compliant standard operating procedure (SOP) for an identified scenario in the MedTech sector.
7
Risk Management (ISO 14971)
Verified
Key Learning Objectives:
- Review the principles, scope and evolution of risk management in MedTech.2.
- Discuss the essential features of the ISO 14971 standard in the MedTech sector.3.
- Explore the benefits and challenges for an organisation implementing the ISO 14971 standard within the MedTech sector.4.
- Explain how the ISO 14971 standard can be applied to a given MedTech scenario.
8
Software and UI/UX Design
Verified
Key Learning Objectives:
- Explore the range of software development methodologies that can be used in developing MedTech applications.2.
- Explain the principles of user interface (UI) design used in MedTech systems.3.
- Review the concepts of user experience (UX) design used in MedTech systems.4.
- Develop an effective UI/UX prototype for an identified MedTech scenario.
Regulatory & Verification Details
- Qualification Number (QN)
- 610/6104/9
- Regulated Status
- Available to learners
- Awarding Body
- Pearson
- Qualification Type
- Other Vocational Qualification
- Operational Start
- Sept 2026