The aim of this training is to provide participants with a strong foundation in key aspects of Medical Device Manufacturing
Learner profile:
Candidates should at minimum have completed the Junior Cert with pass grades in at least five ordinary level subjects (including Maths and English).
What you will get:
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.
Course Content (Modules):
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
Innopharma Certificate of Completion
Live online classes delivered over 10 evenings
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