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.