Oakland University
Wednesday, September 17, 2014

FDA Workshop Receives Approval

OU INC hosted the third in their Growing Your Business, Tools For Success Workshop Series on June 24th. Presented by Steve Goldner, the third topic in the series was “FDA Medical Device Getting Approved To Market”. Goldner, a forensic toxicologist and a lawyer, has gotten 230 drugs and medical devices FDA-approved. With 25 years of experience working with large drug companies and the FDA, Goldner had plenty of knowledge to present.

Being a center for numerous innovative medical device startups and accelerators, OU INC was enthused to bring such a prestigious speaker to the event. Breaking down of the three different categories that a medical device can fit in and the process involved to get a device approved in such a category is the first thing that a company needs to know when applying for FDA approval. With each different type of device, the fees, process of approval, and depth of review process can vary.

Goldner informed the audience of the different 510k’s, how to temper expectations, and the time frame for the review process. Goldner also warned of common issues that can arise from developing and evolving technologies such as software issues, hardware validation and verification, and compliancy regulations.

Representing several different medical companies at OU INC, the event was a success. With the extensive experience and vast knowledge that Goldner has in the field, the presentation was informative, captivating, and inspiring. Although the process for approval may seem tough, Goldner’s presentation and track record shows that a company that is innovative and motivated can achieve results.

OU INC hosted the third in their Growing Your Business, Tools For Success Workshop Series on June 24th. Presented by Steve Goldner, the third topic in the series was “FDA Medical Device Getting Approved To Market”. Goldner, a forensic toxicologist and a lawyer, has gotten 230 drugs and medical devices FDA-approved. With 25 years of experience working with large drug companies and the FDA, Goldner had plenty of knowledge to present.

Being a center for numerous innovative medical device startups and accelerators, OU INC was enthused to bring such a prestigious speaker to the event. Breaking down of the three different categories that a medical device can fit in and the process involved to get a device approved in such a category is the first thing that a company needs to know when applying for FDA approval. With each different type of device, the fees, process of approval, and depth of review process can vary.

Goldner informed the audience of the different 510k’s, how to temper expectations, and the time frame for the review process. Goldner also warned of common issues that can arise from developing and evolving technologies such as software issues, hardware validation and verification, and compliancy regulations.

Representing several different medical companies at OU INC, the event was a success. With the extensive experience and vast knowledge that Goldner has in the field, the presentation was informative, captivating, and inspiring. Although the process for approval may seem tough, Goldner’s presentation and track record shows that a company that is innovative and motivated can achieve results.



Created by Joesph Ciaravino (jaciarav@oakland.edu) on Wednesday, September 17, 2014
Modified by Joesph Ciaravino (jaciarav@oakland.edu) on Wednesday, September 17, 2014
Article Start Date: Wednesday, September 17, 2014