Webinar Medical Devices 101 - Overview of Key Regulatory Requirements - Do’s, Don’ts and Real-World Examples

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar

"Listen From Angela Bazigos who recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom"

This course is intended to provide an overview of the regulatory requirements for medical devices or what is sometimes referred to as Devices 101.


By Top FDA Expert 30+ years exp.

FDA`s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions.
Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval. 

Why should you attend

THIS COURSE IS A COMPILATION OF INFORMATION THAT HAS BEEN DEVELOPED BY AND IS USED BY THE FDA FOR TRAINING. By taking this course, you are learning the latest in the Agency’s thinking, as described by Agency experts on the subject!!

By attending this course you will learn:

•     Information about the Center for Devices and Radiological Health
•     What products are regulated as medical devices
•     How to determine the classification of your medical device
•     What controls are used for medical devices
•     How to ensure your establishment is registered correctly
•     Requirements for Pre-Market Notification 510(k)
•     Requirements for Pre-Market Approval (PMA)
•     What is an Investigational Device Exemption (IDE) and how to use it
•     How to label Medical Devices
•     Requirements for Quality System Regulation
•     How to ensure that you are reporting correctly on your Medical Devices
•     Follow up studies once the device is on the market and device tracking

Areas Covered

•       Overview of Center for Medical Devices & Radiological Health (CDRH)
        o Background
        o Organizational Chart
        o CDRH Mission
•       Medical Device Classification
        o Medical Device Regulations Details
        o Medical Device Classification & Risk Categorization
        o Example
•       Medical Devices Overview
        o Definition
        o Examples of Products Regulated as Medical Devices
        o FDA Regulations for Medical Devices
•       Medical Device Controls
        o General Controls
        o Special Controls
•       Establishment Registration
•       Pre-Market Notification 510(k)
        o Pre-Market Notification 510(k) Overview
        o When is a 510(k) Required
        o Devices Exempt from 510(k)
        o 510(k) Programs
        o 510(k) Device User Fee
•       Pre-Market Approval (PMA)
        o Pre-Market Approval Overview
        o Pre-Market Approval User Fee
•       Investigational Device Exemption (IDE)
•       Medical Device Labeling
•       Quality System Regulation (QSR)
•       Medical Device Reporting (MDR)
•       Post Market Studies and Medical Device Tracking
        o Post Market Studies
        o Medical Device Tracking

Who will Benefit

•        CEOs
•        VPs
•        Hospital Administrators
•        Nurses
•        Doctors
•        Regulatory VP
•        Quality VPs
•        IT VPs
•        Regulatory Affairs professionals
•        Quality Managers
•        Quality Engineers
•        Small business owners
•        GxP practitioners
•        Consultants
•        Regulators

Industries who can attend

Medical Device Industry

Speaker Profile

Angela Bazigos

Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA.  Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences.

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