Medical Device Design Control
Overview:
Understanding, interpreting, and implementing design control requirements in a holistic manner can significantly expedite the regulatory processes, bringing innovative medical products to the global market faster and saving enormous amount of your unnecessary time, efforts and investment.
In this presentation, you will get familiar with regulatory and quality requirements of design control concerning medical devices, active implantable medical devices and IVDs.
This webinar will greatly help medical device industry and relevant professionals establish and maintain adequate design control procedures.
Why Should You Attend: Device manufacturers are required to establish and maintain the FDA-compliant quality management systems, where appropriate and applicable, including design control. This webinar is intended to provide guidance on understanding, interpreting, and implementing design control requirements. This presentation is further intended to help you establish and maintain adequate design control procedures for all classes of medical devices including IVDs.
Areas Covered in the Session:
- Federal Statutes and Regulations Governing Medical Devices in the US
- Introduction and Definitions
- Design and Development Planning
- Design Input
- Design Output
- Design Review
- Design Verification And Validation including Software Validation
- Design Transfer
- Design Changes
- Design History File (DHF)
- Device History Record (DHR) and Device Master Record (DMR)
Who Will Benefit:
- R&D Scientists, Engineers, Managers, and Directors
- Regulatory Affairs
- Quality Professionals
- Product Development Professionals
- CROs
- Consultants
- Senior Management
- Contractors and Subcontractors
- Anyone interested in design control