Medical Device Approvals Process
Venue: Toronto, Canada
Event Date/Time: Mar 03, 2008 | End Date/Time: Mar 04, 2008 |
Description
A Two-Day Comprehensive & Interactive Course with Workshops on:
- FDA's Center for Devices and Radiological
Health Investigations
- Clarifying FDA Classification of Medical
Devices
- Memoranda of Understanding (MOU)
- Developing QSR/GMP/ISO for combo products
- Principals of ICH GCP for Medical Devices
- Definitions and Classifications of Medical
Device
- The Premarket Notification (510K) Summaries
and Reviews
- Investigational Device Exemption (IDE)
Applications
- Premarket Approval (PMA) Review Process
- Safety and Effectiveness Requirements
- Humanitarian Device Exemption (HDE)
- Post Market Obligations
- Managing Recalls and Problem Reporting
- Planning and Implementing an Clinical Audit
- Determining a Regulatory Strategy
- Clinical Trials for Medical Devices
- Sponsor Obligations
- Inspection and Audit of Vendors
- FDA Notification procedures