Regulatory Compliance in Medical Technology
( 30 Modules )

Module #1
Introduction to Regulatory Compliance in Medical Technology
Overview of the importance of regulatory compliance in medical technology, including the role of regulatory agencies and the consequences of non-compliance.

Module #2
Global Regulatory Framework
Overview of the global regulatory framework for medical technology, including the FDA, EUs MDR, and other international regulations.

Module #3
FDA Regulations for Medical Devices
In-depth review of FDA regulations for medical devices, including classification, premarket notification, and postmarket surveillance.

Module #4
EUs Medical Device Regulation (MDR)
In-depth review of the EUs MDR, including classification, conformity assessment, and CE marking.

Module #5
ISO 13485:Medical Device Quality Management
Overview of the ISO 13485 standard for medical device quality management, including risk management and quality system requirements.

Module #6
Risk Management for Medical Devices
Principles and practices of risk management for medical devices, including risk analysis, risk evaluation, and risk control.

Module #7
Labeling and Advertising Regulations
Overview of labeling and advertising regulations for medical devices, including FDA and EU requirements.

Module #8
Clinical Trials and Investigational Device Exemptions (IDEs)
Overview of clinical trials and IDEs, including FDA regulations and EU Clinical Trials Regulation.

Module #9
Postmarket Surveillance and Vigilance
Overview of postmarket surveillance and vigilance requirements, including reporting of adverse events and product recalls.

Module #10
Medical Device Software and Cybersecurity
Overview of medical device software and cybersecurity regulations, including FDA and EU requirements.

Module #11
Sterilization and Packaging Validation
Overview of sterilization and packaging validation requirements for medical devices.

Module #12
Quality System Regulation (QSR) and Design Controls
Overview of QSR and design controls, including design verification, design validation, and design transfer.

Module #13
Audits and Inspections
Overview of audits and inspections, including FDA and EU requirements, and preparation strategies.

Module #14
Regulatory Submissions and Documentation
Overview of regulatory submissions and documentation requirements, including 510(k), PMA, and CE marking technical files.

Module #15
Compliance for Medical Device Startups
Special considerations for medical device startups, including regulatory strategy and resource management.

Module #16
Compliance for Medical Device Manufacturers
Best practices for medical device manufacturers, including quality system implementation and continuous improvement.

Module #17
Compliance for Medical Device Distributors and Suppliers
Special considerations for medical device distributors and suppliers, including supply chain management and contractual obligations.

Module #18
Regulatory Compliance for Digital Health and AI
Overview of regulatory compliance for digital health and AI, including software as a medical device (SaMD) and artificial intelligence (AI) in medical devices.

Module #19
Compliance for Personalized Medicine and Companion Diagnostics
Overview of regulatory compliance for personalized medicine and companion diagnostics, including genetic testing and precision medicine.

Module #20
Regulatory Compliance for Medical Device Clinical Trials
Best practices for regulatory compliance in medical device clinical trials, including trial design and conduct.

Module #21
Regulatory Compliance for Medical Device Combination Products
Overview of regulatory compliance for medical device combination products, including drug-device and biologic-device combinations.

Module #22
Regulatory Compliance for Medical Device Export and Import
Overview of regulatory compliance for medical device export and import, including customs regulations and tariffs.

Module #23
Regulatory Compliance for Medical Device Labeling and Advertising
Best practices for regulatory compliance in medical device labeling and advertising, including promotions and marketing materials.

Module #24
Regulatory Compliance for Medical Device Servicing and Repair
Overview of regulatory compliance for medical device servicing and repair, including maintenance and refurbishment.

Module #25
Regulatory Compliance for Medical Device Disposal and Recycling
Overview of regulatory compliance for medical device disposal and recycling, including environmental regulations.

Module #26
Regulatory Compliance for Medical Device Security and Privacy
Overview of regulatory compliance for medical device security and privacy, including data protection and cybersecurity.

Module #27
Regulatory Compliance for Medical Device Standards and Harmonization
Overview of regulatory compliance for medical device standards and harmonization, including international standards and consensus standards.

Module #28
Regulatory Compliance for Medical Device Packaging and Labeling
Best practices for regulatory compliance in medical device packaging and labeling, including UDI and serialization.

Module #29
Regulatory Compliance for Medical Device Manufacturer Oversight
Overview of regulatory compliance for medical device manufacturer oversight, including quality agreements and supply chain management.

Module #30
Course Wrap-Up & Conclusion
Planning next steps in Regulatory Compliance in Medical Technology career

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Regulatory Compliance in Medical Technology ( 30 Modules )

Regulatory Compliance in Medical Technology
( 30 Modules )