FDA Regulations for Medical Devices
( 25 Modules )

Module #1
Introduction to FDA Regulations for Medical Devices
Overview of FDAs role in regulating medical devices, importance of compliance, and course objectives

Module #2
History of FDA Regulations for Medical Devices
Evolution of FDA regulations, key milestones, and legislative updates

Module #3
FDA Device Classification
Understanding device classification, Class I, II, and III devices, and corresponding regulatory requirements

Module #4
510(k) Premarket Notification
Overview of the 510(k) process, substantial equivalence, and preparation of a 510(k) submission

Module #5
PMA (Premarket Approval) Process
In-depth explanation of the PMA process, requirements, and preparation of a PMA submission

Module #6
IDE (Investigational Device Exemption) Regulations
Understanding IDE regulations, submitting an IDE, and conducting clinical trials

Module #7
Design Controls and Design History File (DHF)
Implementing design controls, creating a DHF, and ensuring compliance with 21 CFR 820.30

Module #8
Medical Device GMP (Good Manufacturing Practices)
Overview of medical device GMP, 21 CFR 820, and quality system regulations

Module #9
Quality System Elements:Management and Organization
Implementing quality system elements, management responsibilities, and organizational structure

Module #10
Quality System Elements:Design and Development
Design and development controls, design verification, and design validation

Module #11
Quality System Elements:Production and Process Control
Production and process control, device labeling, and control of components

Module #12
Quality System Elements:Corrective and Preventive Action (CAPA)
Implementing CAPA, nonconformity control, and corrective action procedures

Module #13
Device Labeling and Serialization
Device labeling requirements, UDI (Unique Device Identification), and serialization

Module #14
Medical Device Reporting (MDR) and Vigilance
MDR regulations, reporting requirements, and global vigilance responsibilities

Module #15
Post-Market Surveillance and Compliance
Post-market surveillance, compliance, and enforcement, and FDA inspections

Module #16
Combination Products and HCT/Ps (Human Cells, Tissues, and Cellular and Tissue-Based Products)
Regulatory considerations for combination products and HCT/Ps

Module #17
Software as a Medical Device (SaMD) and Cybersecurity
Regulatory considerations for SaMD, cybersecurity, and medical device software

Module #18
Human Factors and Usability
Human factors, usability, and user-centered design in medical device development

Module #19
FDA Inspections and Enforcement
Preparing for FDA inspections, responding to FDA 483s, and enforcement actions

Module #20
Medical Device Recalls and Corrections
Recall procedures, correction and removals, and FDA notification

Module #21
International Regulations and CE Marking
Overview of international medical device regulations, CE marking, and global market access

Module #22
Canada and Health Canada Regulations
Overview of Canadian medical device regulations, licensing, and compliance

Module #23
EU MDR and IVDR Regulations
In-depth explanation of EU MDR and IVDR regulations, implementation, and compliance

Module #24
Global Medical Device Regulations and Harmonization
Global medical device regulations, harmonization efforts, and international cooperation

Module #25
Course Wrap-Up & Conclusion
Planning next steps in FDA Regulations for Medical Devices career

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FDA Regulations for Medical Devices ( 25 Modules )

FDA Regulations for Medical Devices
( 25 Modules )