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

Distinguished Course Leaders

Martha A. Feldman, RAC
President & CEO
Drug & Device Development Co., Inc.

Albert A. Ghignone, MS, RAC
CEO
AAG Incorporated