Medical Device Regulations
About This Course
Navigate the complex world of medical device regulation and get your products to market faster. This course covers both US and EU requirements, so you understand all your options for bringing devices to market. You'll learn how to choose the right regulatory pathway—whether that's 510(k), PMA, De Novo, or CE marking—and what each one requires. We break down the confusing parts of device regulation into clear, actionable steps. You'll understand device classification, quality management systems, clinical evaluation requirements, and post-market surveillance obligations. Whether you're developing a simple Class I device or a complex Class III implantable, this course shows you exactly what you need to do. We cover real examples of successful submissions and common mistakes to avoid, so you can save time and money while ensuring compliance.
What's Included
Course Format
Self-paced, on-demand learning with lifetime access. Complete at your own speed with no deadlines.
Key Topics Covered
What You'll Learn
- Navigate FDA medical device pathways
- Understand EU MDR requirements
- Prepare 510(k) and PMA submissions
- Obtain CE marking for devices
- Manage post-market requirements
Course Outcomes
By the end of this course, you will be able to:
- Navigate FDA medical device pathways
- Understand EU MDR requirements
- Prepare 510(k) and PMA submissions
- Obtain CE marking for devices
- Manage post-market requirements
Who Should Take This Course
- Medical device regulatory professionals
- Quality assurance specialists
- R&D professionals
- Regulatory consultants
Course Content
Module 1: FDA Device Regulations
- Device classification
- 510(k) clearance process
- PMA approval process
- De Novo pathway
Module 2: EU MDR
- MDR framework overview
- Device classification
- Conformity assessment
- Notified body processes
Module 3: Quality Systems
- ISO 13485 requirements
- QMS for medical devices
- Design controls
- Risk management (ISO 14971)
Module 4: Clinical Evaluation
- Clinical evaluation requirements
- Clinical investigation
- Post-market clinical follow-up
- Clinical evidence
This course is delivered through Thinkific. You'll receive access instructions after enrollment.