Pearson
    Level 5
    QN: 610/6105/0
    Curriculum Active

    Pearson BTEC Level 5 Higher National Diploma in MedTech for England

    Official qualification regulated by Ofqual, awarded by Pearson. Classified as a Other Vocational Qualification. Total guided learning hours: 1440 hours.

    Qualification Level
    Level 5
    Awarding Body
    Pearson
    Syllabus Units
    24 Units
    Guided Hours
    1440 hrs
    Instant access to interactive lessons, quizzes, and spaced revision.

    Course Syllabus & Study Modules

    Complete breakdown of verified curriculum topics and learning objectives.

    1

    Advanced Manufacturing

    Verified
    Key Learning Objectives:
    • Review a range of advanced manufacturing techniques in the MedTech sector.2.
    • Discuss the optimisation of manufacturing techniques within the MedTech sector.3.
    • Explore the sustainability considerations for organisations manufacturing MedTech devices.4.
    • Develop a regulatory-compliant advanced manufacturing process for an identified medical device.
    2

    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.
    3

    Computer Systems Validation

    Verified
    Key Learning Objectives:
    • Review the key principles and regulatory requirements of CSV in MedTech.2.
    • Explain the development and validation life cycle process in MedTech.3.
    • Explore the range of additional considerations when performing CSV in MedTech.4.
    • Develop a CSV audit strategy for an identified MedTech scenario.
    4

    Data Analytics

    Verified
    Key Learning Objectives:
    • Examine the fundamental principles of business informatics and their application in decision-making within the MedTech industry.2.
    • Plan a data analysis methodology for a given scenario within the MedTech sector.3.
    • Implement a data analysis plan for a given scenario within the MedTech sector.4.
    • Develop data-driven recommendations to inform decision-making for a given business scenario within the MedTech industry.
    5

    Data Management and Cybersecurity

    Verified
    Key Learning Objectives:
    • Review the various types of medical data and the importance of data governance in MedTech.2.
    • Discuss the legal and ethical considerations for data security and patient privacy.3.
    • Assess the cybersecurity threats and vulnerabilities associated with MedTech devices.4.
    • Develop a range of strategies to mitigate cybersecurity threats for an identified MedTech scenario.
    6

    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.
    7

    DevOps Engineering

    Verified
    Key Learning Objectives:
    • Explore the fundamental principles, tools and practices of DevOps in the MedTech industry.2.
    • Explain the benefits and challenges of applying a DevOps methodology to organisations within the MedTech sector.3.
    • Analyse the regulatory compliance, security and privacy practices in MedTech DevOps.4. Design a DevOps methodology for an identified scenario within the MedTech sector.
    8

    Emerging Trends and Technologies

    Verified
    Key Learning Objectives:
    • Review a range of emerging trends and technologies applicable to the MedTech sector.2.
    • Assess the importance of legal, ethical and regulatory considerations when using emerging trends and technologies in MedTech.3.
    • Analyse the challenges and opportunities associated with integrating emerging trends and technologies into MedTech systems and infrastructure.4.
    • Investigate the contribution of emerging trends and technologies as a tool to support MedTech organisations, clinical workflows and patient care.
    9

    Good Practices in MedTech

    Verified
    Key Learning Objectives:
    • Explain the importance of good manufacturing practices (GMP) in MedTech.2.
    • Discuss a range of good manufacturing practices in MedTech.3.
    • Assess the importance of good distribution and documentation practices in MedTech.4.
    • Develop a regulatory-compliant good practice protocol for an identified scenario in MedTech.
    10

    Hardware, Robotics and Autonomous Systems in MedTech

    Verified
    Key Learning Objectives:
    • Discuss the principles and components of hardware systems in MedTech applications.2.
    • Analyse the role of robotics in a range of MedTech applications.3.
    • Explore the use of autonomous systems in a range of MedTech applications.4.
    • Evaluate the regulatory, ethical and safety aspects of hardware, robotics and autonomous systems in medical applications.
    11

    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.
    12

    ISO Standard Auditing for Medical Devices

    Verified
    Key Learning Objectives:
    • Explain the purpose of audits in MedTech.2.
    • Discuss the different types of audits in MedTech.3.
    • Review the audit requirements for ISO standards compliance in MedTech.4. Compare and contrast a range of ISO standard compliance audit checklists.
    13

    Managing a MedTech Project (Pearson Set)

    Verified
    Key Learning Objectives:
    • Explore the key elements of project life cycle management within the MedTech sector.2. Devise a project management plan for a MedTech project to meet a set of defined objectives.3.
    • Implement a project management plan for a MedTech project to meet a set of defined objectives.4.
    • Review the effectiveness of a planned MedTech project against a set of starting objectives.
    14

    Manufacturing Processes

    Verified
    Key Learning Objectives:
    • Discuss the importance of manufacturing processes for medical devices.2.
    • Review the common manufacturing methods used for medical devices.3.
    • Explain the importance of material selection and product cleanliness in the manufacturing of medical devices.4.
    • Develop a manufacturing process for an identified medical device.
    15

    Marketing and Sales Approaches

    Verified
    Key Learning Objectives:
    • Analyse the impact of the regulatory context on the sales and marketing of MedTech devices.2.
    • Discuss sales models, customer segmentation, pricing and financial strategies in MedTech.3. Design a data-driven MedTech sales and marketing campaign aligned with business and clinical objectives.4.
    • Evaluate the effectiveness of the identified sales and marketing campaign in compliance with regulations.
    16

    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.
    17

    Professional Development

    Verified
    Key Learning Objectives:
    • Examine the process of reflection and its application and challenges in professional practice.2.
    • Discuss the need for continuing professional development (CPD) and its role within the MedTech sector.3. Deliver a workshop on an identified MedTech topic that shows professionalism.4. Design a CPD plan for a range of identified objectives based on workshop feedback.
    18

    Quality by Design (QbD)

    Verified
    Key Learning Objectives:
    • Explain the purpose of Quality by Design (QbD) in the MedTech sector.2.
    • Discuss the business applications of QbD within the MedTech sector.3.
    • Review the design applications of QbD in the MedTech sector.4.
    • Develop a regulatory-compliant QbD methodology for an identified scenario in the MedTech sector.
    19

    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.
    20

    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.
    21

    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.
    22

    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.
    23

    Understanding User Needs

    Verified
    Key Learning Objectives:
    • Explain the concepts of user needs analysis and their role in MedTech.2.
    • Review a range of methodologies for collecting and validating user insights.3.
    • Assess the ways in which user needs analysis can have an impact on MedTech products.4. Design a user needs assessment for an identified MedTech scenario.
    24

    Work-Based Experience

    Verified
    Key Learning Objectives:
    • Describe the key aspects of work experience in the MedTech sector.2.
    • Report on the changing nature of work within the MedTech sector.3.
    • Undertake a work experience placement within the MedTech sector.4.
    • Review professional conduct and the learning experience following a placement in the MedTech sector.

    Regulatory & Verification Details

    Qualification Number (QN)
    610/6105/0
    Regulated Status
    Available to learners
    Awarding Body
    Pearson
    Qualification Type
    Other Vocational Qualification
    Operational Start
    Sept 2026

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