Course Content (Modules):

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

Certification / Awarding Body:

 Innopharma Certificate of Completion

Duration/Delivery Mode:

Live online classes delivered over 5 days