Medical Devices 101: An Educational Forum- San Antonio, TX

We are pleased to announce Medical Devices 101: An Educational Forum on August 13, 2018. Because there is a limited capacity for this event, we recommend advanced registration.

Location

Norris Conference Center-San Antonio

Park North Shopping Center

618 Northwest Loop 410 #207, San Antonio, TX 78216

 

Date and Time

Monday August 13, 2018

08:00 AM – 05:00 PM Central

 

Price

Regular Registration (registration is open) US$ 150.00- morning refreshments and box lunch included

Register Now

 

Description

This educational forum is intended for folks with little to no experience with FDA requirements for medical device manufacturers, specification developers, and initial distributors of imported devices. It is particularly useful to entrepreneurs, very small start-up companies, new hires, students planning a career in the medical device industry or enforcement, and administrative and marketing employees in medical device firms.

The Food and Drug Administration is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. 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.

The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are:

– Establishment registration,

– Medical Device Listing,

– Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA),

– Investigational Device Exemption (IDE) for clinical studies

– Quality System (QS) regulation,

– Labeling requirements, and

– Medical Device Reporting (MDR)

Medical Devices 101 provides a brief overview of all of the above to folks new to the medical device industry.

 

Speakers

Al Alonso representing the industry viewpoint.

Dr. John Criscione, Biomedical Engineering professor, Texas A&M.

Jeff Wooley, FDA Compliance Officer, Dallas District.

 

Dress Code

Business Casual

 

Contact

Cymbre Kooker, Secretary, FDMIC, Inc.

cymbre.kooker@fda.hhs.gov