Medical Devices: US Law, Regulation and Practice 2016

Topics

• Pre-market
  • Pre-submission meetings
  • Design control
• What is a device
  • Regulation and guidance and the role of each
  • How can you tell if your product is a medical device
  • Determining your classification
• The "different" products
  • IVDs and LDTs
  • Combination Products
  • Software
• Marketing submissions
  • 510(k)
  • PMA
  • De novo
• Post marketing
  • CAPA
  • QSR
  • Inspections
  • Reporting
  • Export for foreign markets
• Clinical Trials
  • Other
  • IDE
  • Common problems in trial design and management
  • Export for trials

Who should Attend

Attendees involved or interested in:

• Starting a company to sell health-related products
• Non-regulatory or QA areas of medical device companies
• Selling medical devices
• Financing a health care company