The LICQual ISO 13485:2016 Medical Devices Quality Management Systems Lead Implementer course is a specialised qualification designed to equip professionals with the expertise required to implement, manage, and maintain ISO 13485:2016 standards within medical device organisations. As global healthcare industries demand strict compliance and quality assurance, this programme provides learners with the skills to lead implementation projects, manage risks, and ensure regulatory alignment.
Learners will gain a deep understanding of ISO 13485:2016 requirements, including management responsibilities, risk management, design and development, production, service provision, and post‑market surveillance. The course blends theoretical knowledge with practical application, preparing participants to address real‑world challenges in medical device quality systems. By completing this qualification, learners achieve professional recognition, enhance employability, and contribute to organisational excellence in the medical device sector.
Course Overview
- Qualification Title: LICQual ISO 13485:2016 Medical Devices Quality Management Systems Lead Implementer
- Awarding Body: LICQual
- Total Units: 06 units
- Credits: 40
- Guided Learning Hours (GLH): 120
Course Study Units
- Introduction to ISO 13485: Purpose, Scope, and Structure
- Management Requirements
- Risk Management
- Design and Development
- Production and Service Provision
- Post‑Market Surveillance
Course Learning Outcomes
Unit 1: Introduction to ISO 13485: Purpose, Scope, and Structure
- Understand the purpose and scope of ISO 13485:2016.
- Recognise the structure and key clauses of the standard.
- Apply foundational principles to medical device quality systems.
Unit 2: Management Requirements
- Analyse leadership responsibilities in ISO 13485 implementation.
- Apply management review processes to ensure compliance.
- Establish quality objectives and policies aligned with ISO standards.
Unit 3: Risk Management
- Identify risks in medical device design and production.
- Apply risk assessment methodologies to ensure patient safety.
- Implement risk control measures in line with ISO 14971 integration.
Unit 4: Design and Development
- Understand design and development requirements under ISO 13485.
- Apply documentation and validation processes.
- Ensure compliance in product lifecycle management.
Unit 5: Production and Service Provision
- Implement production controls to maintain product quality.
- Apply validation and verification techniques in service provision.
- Ensure traceability and compliance in manufacturing processes.
Unit 6: Post‑Market Surveillance
- Understand post‑market surveillance requirements.
- Apply monitoring and reporting systems for product performance.
- Ensure corrective and preventive actions are effectively implemented.
Course Benefits
This qualification provides learners with advanced knowledge and leadership skills to implement ISO 13485:2016 effectively. It enhances professional credibility and prepares participants to lead compliance projects in medical device organisations.
- Gain internationally recognised certification.
- Develop expertise in ISO 13485 implementation.
- Enhance employability in medical device industries.
- Strengthen leadership and management skills.
- Learn risk management and compliance strategies.
- Build confidence in design, production, and surveillance processes.
- Contribute to organisational excellence and patient safety.
Ideal Learner
This course is designed for individuals motivated to advance their careers in medical device quality management. It suits learners who want to combine technical expertise with leadership and compliance knowledge.
- Quality assurance professionals.
- Regulatory compliance officers.
- Medical device engineers.
- Project managers in healthcare industries.
- Consultants specialising in ISO standards.
- Career changers entering medical device quality management.
- Professionals seeking international recognition.
Entry Requirements
Learners must meet the following minimum entry requirements to enrol:
- Minimum Age: 18 years or above.
- Educational Background: A Level 5 qualification or equivalent in engineering, healthcare, or related fields.
- Experience: Prior exposure to medical device manufacturing or quality assurance roles is recommended.
- Language Proficiency: Ability to communicate effectively in English, recommended CEFR B2 level or equivalent (IELTS 6.0).
Who Can Enrol
This qualification is open to a wide range of learners and professionals seeking to enhance their knowledge of ISO 13485:2016. It is suitable for both experienced practitioners and those progressing academically.
- Medical device engineers and technicians.
- Quality assurance and control specialists.
- Regulatory compliance professionals.
- Organisations upskilling their workforce.
- International learners seeking global recognition.
- Public sector employees in healthcare roles.
- Consultants specialising in medical device compliance.
Future Progression
Completing this diploma opens pathways to advanced study and career opportunities in medical device quality management, regulatory affairs, and leadership. Learners can progress to postgraduate qualifications, senior management roles, or specialised certifications in ISO standards and healthcare compliance. This course also strengthens employability in international markets, supporting career growth in manufacturing, consultancy, and healthcare leadership.