The Regulatory Process for Medical Device Approval

  • Course Price: $150 USD
  • Course Run Time: 57 minutes
  • Course Level: Level 2 - General
  • Completion Period: 2 week

The Regulatory Process for Medical Device Approval explains how medical devices are regulated in the United States. Medical device classification and each classification’s differing approval pathways are discussed in detail. FDA guidelines, quality system regulations, and risk management plans are also discussed in great detail. If you are new to the medical device industry, this class will provide an understanding of the breadth of the industry’s regulatory requirements.

Suggested Prerequisites

Diagnostics’ Role in Medicine Today

Takeaways
  1. Identify the medical device industry's major device sectors and worldwide regulatory organizations.
  2. Classify medical devices based on potential risks.
  3. Explain the major medical device approval pathways.
  4. Discuss how the Code of Federal Regulations and Good Practices enforces regulatory compliance.
  5. Develop a risk management plan for a medical device.
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent
Download Agenda
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent
Trailer
Overview of Medical Device Types
Identifies the major medical device sectors and describes the history of medical device regulation.
FDA Medical Device Classification
Explains how to classify medical devices into Class I, Class II, or Class III based on risk assessment.
FDA Approval Pathways for Medical Device
Maps the medical device approval pathways, including how approval of a product can be obtained if a new device is being compared to a predicated device.
FDA Regulatory Compliance for Medical Device
Surveys various compliance laws including the Code of Federal Regulations, Good Lab Practices, Good Clinical Practices, and current Good Manufacturing...More
Medical Device Risk Management Plans
Demonstrates how to develop a risk management plan for a medical device.
Medical Device Regulatory Bodies Worldwide
Lists the worldwide regulatory bodies for medical devices.
Final Quiz
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent