Quality Assurance in Medical Device Production
( 25 Modules )

Module #1
Introduction to Quality Assurance in Medical Device Production
Overview of the importance of quality assurance in medical device production and the role of regulatory agencies.

Module #2
Regulatory Framework for Medical Devices
Overview of relevant regulations, standards, and guidelines for medical device production, including FDA, ISO, and EU MDR.

Module #3
Quality Management System (QMS) Fundamentals
Introduction to QMS principles, including quality policy, objectives, and organizational structure.

Module #4
Risk Management in Medical Device Production
Understanding risk management principles and their application in medical device production.

Module #5
Design Controls and Design Verification
Design control principles, design input, design output, and design verification.

Module #6
Design Validation and Design Transfer
Design validation principles, design transfer, and design changes.

Module #7
Production and Process Control
Production and process control principles, including manufacturing processes, equipment, and personnel.

Module #8
Material Control and Supply Chain Management
Material control principles, including material selection, procurement, and supply chain management.

Module #9
Device Master Record (DMR) and Device History Record (DHR)
Understanding DMR and DHR, including content, maintenance, and control.

Module #10
Corrective and Preventive Action (CAPA)
CAPA principles, including identifying and correcting defects, and implementing preventive actions.

Module #11
Complaint Handling and Adverse Event Reporting
Complaint handling principles, including adverse event reporting and regulatory requirements.

Module #12
Internal Audits and Management Review
Internal audit principles, including audit planning, execution, and reporting, and management review processes.

Module #13
Supplier Quality Management
Supplier quality management principles, including supplier selection, evaluation, and control.

Module #14
Serialization and Track-and-Trace
Understanding serialization and track-and-trace principles, including regulatory requirements and implementation.

Module #15
Sterilization and Sterility Assurance
Sterilization principles, including methods, validation, and control, and sterility assurance principles.

Module #16
Packaging and Labeling
Packaging and labeling principles, including regulatory requirements and control.

Module #17
Environmental and Climate Controls
Environmental and climate control principles, including control of temperature, humidity, and other environmental factors.

Module #18
Quality Metrics and Performance Indicators
Understanding quality metrics and performance indicators, including data analysis and trending.

Module #19
Continuous Improvement and Lean Manufacturing
Introduction to continuous improvement and lean manufacturing principles, including waste reduction and process optimization.

Module #20
Medical Device Recalls and Field Actions
Medical device recall principles, including recall planning, execution, and reporting, and field action principles.

Module #21
Post-Market Surveillance and Vigilance
Post-market surveillance and vigilance principles, including adverse event reporting and regulatory requirements.

Module #22
Quality Assurance in Combination Products
Quality assurance principles in combination products, including drug-device and biologic-device combinations.

Module #23
Quality Assurance in Software-As-A-Medical-Device (SaMD)
Quality assurance principles in SaMD, including software development, testing, and validation.

Module #24
Quality Assurance in Digital Health Technologies
Quality assurance principles in digital health technologies, including mobile medical apps, wearables, and telemedicine.

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Quality Assurance in Medical Device Production career

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Quality Assurance in Medical Device Production ( 25 Modules )

Quality Assurance in Medical Device Production
( 25 Modules )