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Essential Skills for Medical Device Manufacturing

To provide learners with an understanding of Medical Device Manufacturing, covering key industry aspects, market dynamics, QMS systems, regulatory compliance, the principles of Operational Excellence, fundamentals of Risk Management and CAPA systems.

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Description

Learner profile:

Candidates who wish to develop a career within the Medical Device industry.

Candidates within the Medical Device industry and wish to upskill and gain a wider understanding of the sector.

Learner prerequisites:

Learners should at minimum have completed the Junior Cert with pass grades in at least five ordinary level subjects (including Maths and English).

Learning outcomes:

Learners will develop key essential knowledge in the areas of product quality, quality management systems, regulatory compliance, design and development of medical devices, assembly and packaging, inspection, validation and review future trends for the sector.

  • Identify key players, market dynamics, global impact, career opportunities and skills required in the medical device industry.
  • Describe emerging technologies, market trends, and sustainability practices shaping the future of medical device manufacturing.
  • List components and functions of Quality Management Systems and regulatory compliance requirements in the medical device industry.
  • Define principles and methodologies of Lean, Six Sigma and Operational Excellence (OpEx).
  • State essential elements of risk management and Corrective Actions (CAPA) systems, including handling complaints, audits and compliance with ISO standards and regulations.

Describe key steps and methods in process validation, testing, assembly, packaging and traceability of medical devices, including Unique Device Identification (UDI) requirements.


Course Content:

Day 1: Overview of Medical Device Industry and Manufacturing


Module 1.1: Industry Overview



  • Definition & Classification of Medical Devices



  • Key Players & Market Dynamics



  • Global Impact & Importance


Module 1.2: Regulatory Landscape



  • FDA, CE, ISO Standards



  • Device Approval Process



  • Quality System Regulation (QSR)


Module 1.3: Medical Device Manufacturing Terminology



  • Glossary of Key Terms



  • Understanding Industry Jargon


Day 2: Design and Development of Medical Devices


Module 2.1: Design Controls and Principles



  • Concept & Design Development



  • Prototyping & User-Centred Design



  • Design Verification & Validation


Module 2.2: Material Selection and Biocompatibility



  • Materials used in Medical Devices



  • Biocompatibility Testing & Standards



  • Sterilisation Techniques & Considerations


Module 2.3: Process Validation and Testing



  • Validation Strategies & Methods



  • In-process Testing & Inspection



  • Reliability Testing & Failure Analysis


Day 3: Medical Device Assembly and Packaging


Module 3.1: Assembly Techniques and Considerations



  • Cleanroom Assembly



  • Automation in Assembly



  • Process Monitoring & Control


Module 3.2: Packaging and Sterilization



  • Packaging Materials & Methods



  • Sterilisation Techniques & Validation



  • Packaging Integrity & Shelf-life Testing


Module 3.3: Labelling and Traceability



  • Labelling Requirements & Standards



  • UDI (Unique Device Identification)



  • Traceability & Recall Management


Day 4: Quality Management and Regulatory Compliance


Module 4.1: Quality Management Systems (QMS)



  • ISO 13485 Standards



  • Documentation & Record Keeping



  • Audits & Inspections


Module 4.2: Risk Management and CAPA



  • Risk Assessment & Mitigation



  • Corrective and Preventive Action (CAPA) System



  • Handling Complaints & Adverse Events


Module 4.3: Regulatory Submissions and Approvals



  • Pre-market Notification



  • Pre-market Approval



  • Post-Market Surveillance & Reporting


Day 5: Opportunities, and Future Trends in Medical Device Manufacturing


Module 5.1: Emerging Technologies and Market Trends



  • Additive Manufacturing & 3D Printing



  • Wearables & Digital Health Devices



  • Sustainable Manufacturing & Environmental Considerations


Module 5.2: Career Paths and Development



  • Roles in Medical Device Manufacturing



  • Skills & Qualifications Required


Career Progression & Development

Duration:

25 hours

Exam/Continuous Assessment details

Short Exercise/Quiz 

Certification/Awarding Body/Credits:

Vendor Certificate of Completion

Progression Pathway:

  • Certificate in Operational Excellence (Special Purpose Award/QQI Level 6 – 25 Credits) (AMC22150) or

  • Certificate in Supply Chain Operations (Special Purpose Award/QQI Level 6 – 25 Credits) (AMC22151)