Regulatory Compliance for Medical Device Software
( 25 Modules )

Module #1
Introduction to Regulatory Compliance
Overview of regulatory compliance for medical device software, importance and benefits

Module #2
Global Regulatory Framework
Overview of global regulatory frameworks for medical devices, including FDA, EU MDR, and ISO 13485

Module #3
Medical Device Classification
Understanding medical device classification, including risk-based classification and device categorization

Module #4
Software as a Medical Device (SaMD)
Defining SaMD, including software-based medical devices and mobile medical apps

Module #5
Regulatory Requirements for Software Development
Overview of regulatory requirements for software development, including design controls and verification

Module #6
Software Risk Management
Understanding software risk management, including risk analysis and mitigation strategies

Module #7
Cybersecurity for Medical Device Software
Importance of cybersecurity for medical device software, including threat analysis and mitigation strategies

Module #8
FDA 21 CFR Part 11 and Annex 11
Understanding FDA 21 CFR Part 11 and Annex 11, including electronic records and signatures

Module #9
EU MDR and IVDR Software Requirements
Overview of EU MDR and IVDR software requirements, including technical documentation and conformity assessment

Module #10
ISO 13485 and IEC 62304
Understanding ISO 13485 and IEC 62304, including quality management systems and software lifecycle processes

Module #11
Software Validation and Verification
Understanding software validation and verification, including testing and validation protocols

Module #12
Clinical Evaluation and Clinical Trials
Overview of clinical evaluation and clinical trials, including data analysis and reporting

Module #13
Regulatory Submissions and Approvals
Understanding regulatory submissions and approvals, including 510(k), PMA, and CE marking

Module #14
Post-Market Surveillance and Vigilance
Importance of post-market surveillance and vigilance, including adverse event reporting and recall management

Module #15
Software Change Control and Updates
Understanding software change control and updates, including impact analysis and validation

Module #16
Regulatory Audits and Inspections
Preparing for regulatory audits and inspections, including audit trails and documentation

Module #17
Compliance for Cloud-Based Medical Devices
Understanding compliance for cloud-based medical devices, including data privacy and security

Module #18
Artificial Intelligence and Machine Learning in Medical Devices
Understanding AI and ML in medical devices, including regulatory considerations and ethics

Module #19
Regulatory Compliance for Wearable Devices and Mobile Health
Overview of regulatory compliance for wearable devices and mobile health, including FDA and EU guidelines

Module #20
Compliance for Software as a Service (SaaS) Medical Devices
Understanding compliance for SaaS medical devices, including data protection and security

Module #21
Regulatory Compliance for Medical Device Software in Emerging Markets
Overview of regulatory compliance for medical device software in emerging markets, including China, Japan, and Brazil

Module #22
Quality Management System (QMS) for Medical Device Software
Understanding QMS for medical device software, including ISO 13485 and 21 CFR Part 820

Module #23
Design Controls for Medical Device Software
Understanding design controls for medical device software, including design inputs, outputs, and verification

Module #24
Regulatory Compliance for Medical Device Software Updates and Patches
Understanding regulatory compliance for medical device software updates and patches, including change control and validation

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Regulatory Compliance for Medical Device Software career

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Regulatory Compliance for Medical Device Software ( 25 Modules )

Regulatory Compliance for Medical Device Software
( 25 Modules )