Medical Devices 101: An Educational Forum- Austin, TX

We are pleased to announce Medical Devices 101: An Educational Forum on August 26, 2019. Because there is a limited capacity for this event, we recommend advanced registration.

Agenda

Registration Link

Presentation Slides
Part 1
Part 2
Part 3

Location
Medtomarket (M2M Element)
2101 E St. Elmo, Bldg. 1, Ste. 100
Austin, TX 78744

 

Date and Time
Monday August 26, 2019
08:00 AM – 05:00 PM Central

 

Price
Regular Registration: US$ 150.00- morning and afternoon refreshments and a box lunch included

Student Registration: US$ 75.00- morning and afternoon refreshments and a box lunch included- (we have reserved a few seats for current students at this reduced rate)

Attendees are also invited to attend a free tour of the MedtoMarket building after the event.  The short tour will start at 5pm.  This is a great opportunity for you to see what all MedtoMarket offers that might work for you!  Under one roof, MedtoMarket provides a one-stop shop for medical innovation with its two divisions: M2M Element Coworking and M2M Labs. From office space to bioskills research and training to physician access to multi-use space, MedtoMarket provides everything a startup company needs to bring their visions to life.  The company co-founders are practicing doctors in the medical field so startups receive real-time feedback and real connections and resources.

Medical Devices 101- Description
This educational forum is intended for those 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 those new to the medical device industry.

 

Speakers
Industry Speaker: Beckie Ellis, Vice President RA/QA at Argon Medical Inc., representing the industry viewpoint

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

FDA Speaker: William H. Shackelford, Supervisory Consumer Safety Officer, Division 3/West, Office of Medical Device and Radiological Health Operations

Speaker Bios

Dress Code
Business Casual

 

Contact
Jonnetta Wheaton, Communications Chair, FDMIC, Inc.
Jonnetta.Wheaton@dshs.texas.gov