Quality Assurance in Medical Device Development
( 25 Modules )

Module #1
Introduction to Quality Assurance in Medical Device Development
Overview of the importance of quality assurance in medical device development, regulatory requirements, and industry standards.

Module #2
Regulatory Framework for Medical Devices
In-depth review of global regulatory requirements for medical devices, including FDA, EU MDR, and ISO 13485.

Module #3
Quality Management System (QMS) Fundamentals
Introduction to quality management systems, including ISO 13485 requirements and implementation strategies.

Module #4
Risk Management in Medical Device Development
Principles and methods for identifying, assessing, and mitigating risks in medical device development.

Module #5
Design Controls and Design Verification
Design control principles, design verification methods, and design validation strategies for medical devices.

Module #6
_prototype Development and Testing
Best practices for prototype development, testing, and iteration in medical device development.

Module #7
Supplier Management and Control
Strategies for selecting, evaluating, and monitoring suppliers in medical device development.

Module #8
Manufacturing Process Validation
Methods for validating manufacturing processes, including IQ, OQ, and PQ protocols.

Module #9
Sterilization and Packaging Validation
Principles and methods for validating sterilization and packaging processes for medical devices.

Module #10
Labeling and Packaging Requirements
Regulatory requirements for labeling and packaging of medical devices, including EU MDR and FDA guidelines.

Module #11
Clinical Evaluation and Clinical Trials
Principles and methods for conducting clinical evaluations and clinical trials for medical devices.

Module #12
Post-Market Surveillance and Vigilance
Strategies for conducting post-market surveillance and vigilance activities, including complaint handling and adverse event reporting.

Module #13
Document Control and Record Keeping
Best practices for document control, record keeping, and data management in medical device development.

Module #14
Audits and Inspections
Preparing for and conducting internal audits, as well as responding to regulatory inspections and audits.

Module #15
Corrective and Preventive Actions (CAPA)
Implementing and maintaining effective CAPA systems, including root cause analysis and corrective action strategies.

Module #16
Quality Metrics and Key Performance Indicators (KPIs)
Developing and tracking quality metrics and KPIs to measure quality performance and drive continuous improvement.

Module #17
Human Factors and User Experience
Designing medical devices with human factors and user experience in mind, including usability testing and human-centered design.

Module #18
Software Development and Validation
Principles and methods for developing and validating software for medical devices, including IEC 62304 guidelines.

Module #19
Cybersecurity in Medical Device Development
Best practices for addressing cybersecurity risks in medical device development, including threat modeling and penetration testing.

Module #20
Medical Device Classification and Regulatory Paths
Understanding medical device classification and regulatory paths, including 510(k), PMA, and CE marking.

Module #21
Labeling and Language Requirements
Regulatory requirements for labeling and language, including translation and localization strategies.

Module #22
Product Realization and Launch
Best practices for product realization and launch, including production ramp-up and post-launch monitoring.

Module #23
Quality Assurance in Medical Device Servicing
Strategies for ensuring quality in medical device servicing, including maintenance, repair, and refurbishment.

Module #24
Continuous Improvement and Lean Methodologies
Applying lean methodologies and continuous improvement principles to optimize quality and efficiency in medical device development.

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

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Quality Assurance in Medical Device Development ( 25 Modules )

Quality Assurance in Medical Device Development
( 25 Modules )