Innovations in Quality Assurance for Medical Devices
( 25 Modules )

Module #1
Introduction to Quality Assurance in Medical Devices
Overview of the importance of quality assurance in medical devices, regulatory requirements, and industry trends.

Module #2
History of Quality Assurance in Medical Devices
A review of the evolution of quality assurance in medical devices, including key milestones and regulatory changes.

Module #3
Risk Management in Medical Devices
Principles and practices of risk management in medical devices, including risk analysis, risk evaluation, and risk control.

Module #4
Design Controls and Design Verification
Best practices for design controls, design verification, and design validation in medical device development.

Module #5
Material Selection and Biocompatibility
Criteria for material selection, biocompatibility testing, and regulatory requirements for medical device materials.

Module #6
Manufacturing Process Validation
Principles and practices of process validation, including process development, qualification, and continuous monitoring.

Module #7
Sterilization and Packaging
Methods and validation of sterilization and packaging processes for medical devices.

Module #8
Quality System Regulations and ISO 13485
Overview of quality system regulations, including ISO 13485 and FDA QSR, and their application in medical device manufacturing.

Module #9
Audits and Inspections
Preparation for and execution of internal audits, supplier audits, and regulatory inspections.

Module #10
CAPA and Corrective Action
Best practices for corrective action, preventive action, and continuous improvement in medical device manufacturing.

Module #11
Medical Device Software and Cybersecurity
Regulatory requirements and best practices for software development, testing, and cybersecurity in medical devices.

Module #12
Artificial Intelligence and Machine Learning in Medical Devices
Applications and challenges of AI and ML in medical devices, including regulatory considerations.

Module #13
Digital Health and Medical Device Connectivity
Trends and innovations in digital health, including connectivity, data analytics, and patient engagement.

Module #14
Additive Manufacturing and 3D Printing
Applications and challenges of additive manufacturing and 3D printing in medical device development and production.

Module #15
Nanotechnology and Biomaterials
Applications and challenges of nanotechnology and biomaterials in medical device development, including regulatory considerations.

Module #16
Global Regulatory Requirements for Medical Devices
Overview of regulatory requirements for medical devices in major markets, including EU, US, Canada, and Japan.

Module #17
Post-Market Surveillance and Vigilance
Best practices for post-market surveillance, vigilance, and reporting of adverse events and product complaints.

Module #18
Clinical Evaluation and Investigation
Principles and practices of clinical evaluation and investigation, including clinical trial design and regulatory requirements.

Module #19
Human Factors and Usability Engineering
Best practices for human factors and usability engineering in medical device development, including user-centered design and testing.

Module #20
Labeling and Instructions for Use
Regulatory requirements and best practices for labeling and instructions for use, including user manuals and packaging.

Module #21
Quality Metrics and Performance Indicators
Development and application of quality metrics and performance indicators in medical device manufacturing and quality assurance.

Module #22
Supply Chain Management and Supplier Control
Best practices for supply chain management, supplier selection, and supplier control in medical device manufacturing.

Module #23
Continuous Improvement and Lean Manufacturing
Principles and practices of continuous improvement and lean manufacturing in medical device manufacturing.

Module #24
Quality Culture and Organizational Development
Building a quality culture, including leadership, communication, and training in medical device organizations.

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Innovations in Quality Assurance for Medical Devices career

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Innovations in Quality Assurance for Medical Devices ( 25 Modules )

Innovations in Quality Assurance for Medical Devices
( 25 Modules )