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
