What Device Firms Should Know about Design Control for an Adequate Implementation 2015 is a webinar that covers topics such as:
- Introduction and Definitions
- Federal Statutes and Regulations Governing Medical Devices in the US
- Design Input
- Design and Development Planning
- Design Review
- Design Output
- Design Transfer
- Design Verification And Validation including Software Validation
- Design History File (DHF)
- Design Changes
- Device Master Record (DMR)
- Device History Record (DHR)
- Speaker’s PASS-IT recommendations/suggestions
- Enforcement Actions
What Device Firms Should Know about Design Control for an Adequate Implementation 2015 is intended for:
- Regulatory Affairs
- R&D Scientists, Engineers, Managers, and Directors
- Product Development Professionals
- Quality Professionals
- Consultants
- CROs
- Contractors and Subcontractors
- Senior Management
