Design Controls for Medical Device Quality Assurance
( 30 Modules )

Module #1
Introduction to Design Controls
Overview of design controls, importance in medical device development, and regulatory requirements

Module #2
Design Control Regulations and Standards
In-depth review of FDA, EU, and ISO regulations and standards governing design controls

Module #3
Design Control Principles and Best Practices
Fundamental principles and best practices for implementing design controls in medical device development

Module #4
Design Input and User Needs
Understanding user needs, gathering design inputs, and defining design requirements

Module #5
Design Requirements and Specification
Creating design specifications, validating user needs, and ensuring regulatory compliance

Module #6
Design Input Review and Approval
Reviewing and approving design inputs, verifying design requirements, and documenting design control activities

Module #7
Design Output and Design Description
Creating design outputs, including design descriptions, specifications, and models

Module #8
Design Verification and Testing
Verifying design outputs, testing and validation methods, and documenting results

Module #9
Design Verification and Validation Reports
Preparing design verification and validation reports, summarizing test results, and ensuring regulatory compliance

Module #10
Design Validation and Clinical Evaluation
Validating design outputs, conducting clinical evaluations, and ensuring safety and effectiveness

Module #11
Clinical Evaluation Reports and Summaries
Preparing clinical evaluation reports, summarizing clinical data, and ensuring regulatory compliance

Module #12
Design Validation and Clinical Evaluation Challenges
Addressing common challenges and pitfalls in design validation and clinical evaluation

Module #13
Design Transfer and Production Planning
Transferring design outputs to production, planning production processes, and ensuring regulatory compliance

Module #14
Design Transfer and Production Verification
Verifying design outputs during production, conducting production verification, and documenting results

Module #15
Design Transfer and Production Challenges
Addressing common challenges and pitfalls in design transfer and production

Module #16
Design Changes and Control
Managing design changes, documenting design control activities, and ensuring regulatory compliance

Module #17
Design Change Control Process
Establishing a design change control process, assessing impact, and verifying implementation

Module #18
Design Change Control Challenges
Addressing common challenges and pitfalls in design change control

Module #19
Design Controls and Risk Management
Integrating risk management into design controls, identifying and mitigating risks

Module #20
Risk Analysis and Hazard Evaluation
Conducting risk analysis, hazard evaluation, and mitigating design risks

Module #21
Risk Management and Design Controls
Ensuring design controls address risk management requirements and mitigating design risks

Module #22
Auditing Design Controls
Auditing design control processes, identifying nonconformities, and implementing corrective actions

Module #23
Compliance with Design Control Regulations
Ensuring compliance with FDA, EU, and ISO regulations, and addressing regulatory inspections

Module #24
Design Control Compliance Challenges
Addressing common challenges and pitfalls in design control compliance

Module #25
Design Controls and Regulatory Submissions
Preparing design control documentation for regulatory submissions, including 510(k), PMA, and CE mark

Module #26
Design Control Documentation and Technical Files
Creating and maintaining design control documentation, technical files, and regulatory submissions

Module #27
Design Control and Regulatory Submission Challenges
Addressing common challenges and pitfalls in design control and regulatory submissions

Module #28
Best Practices in Design Controls
Implementing best practices in design controls, lessons learned, and industry benchmarks

Module #29
Case Studies in Design Controls
Real-world examples and case studies in design controls, successes, and challenges

Module #30
Course Wrap-Up & Conclusion
Planning next steps in Design Controls for Medical Device Quality Assurance career

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Design Controls for Medical Device Quality Assurance ( 30 Modules )

Design Controls for Medical Device Quality Assurance
( 30 Modules )