PHARMA/BIOTECH/MEDICAL DEVICES WITH PHONIZE
FDA Overview of Regulatory Requirements for Medical Devices from PHONIZE
Now on Mobile Devices
PHARMA/BIOTECH/MEDICAL DEVICES WITH PHONIZE
FDA Overview of Regulatory Requirements for Medical Devices from PHONIZE
Now on Mobile Devices
The FDA`s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms that manufacture, repackage, relabel, and/or import medical devices sold in the United States.
Medical devices are classified within Classes I-III and regulatory control increases with each class. The device classification regulation defines the regulatory requirements for a general device type, as well as all premarket requirements and expectations. This course is intended to provide a vital overview of the regulatory requirements for medical devices or, as it is sometimes called, Devices 101.
WHAT YOU WILL LEARN
This course will provide you with a comprehensive overview of what products are regulated as medical devices, how to determine the classification of your devices, how to ensure that your establishment is registered correctly, and other information on medical device manufacturing regulations.
AVAILABLE LEVELS
BASIC & INTERMEDIATE
TOPICS COVERED
- Comprehensive overview of the Center for Medical Devices & Radiological Health (CDRH)
- The complete Medical Device Classification system and details
- An overview of medical devices and their individual regulations
- A primer on medical device controls
- All Establishment Registration information, including premarket notification specifics, exemptions, and Pre-Market Approval (PMA)
PERFECT FOR
- CEOs and VPs
- Hospital Administrators
- Doctors and Nurses
- Regulatory, Quality VPs and IT VPs
- Regulatory Affairs professionals
- Quality Managers and Engineers
- Small business owners
- GxP Personnel
- Consultants
- Regulators
“Our quality managers enjoyed using PHONIZE and I appreciated how time and resource effective it is to offer mobile training to my staff.”
Expertly formulated device manufacturing and labelling provides regulatory assurance, improves overall product quality, reduces recalls and shortages, and improves manufacturing consistency.
Utilizing a risk-based approach, this course provides the background and full view of the FDA’s Center for Devices and Radiological Health (CDRH) as it applies to regulations and requirements for medical devices.
Clear, step-by-step guidance helps ensure strategy for delivering high-quality products at a profit with consistent operation of all systems.
Provides skill-building and leadership training for regulated industry professionals with RAPs credit — available now on Mobile Devices.
Utilizes an easy, fast and engaging approach to learning using challenges, game theory and social feedback capabilities.