Stanford BioDesign

7 results found

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510(k) vs. PMA Regulatory Strategies
Holstein Howard
7/28/2011
Summary:

Paul Yock interviews Howard Holstein, regulatory attorney, on 510(k) vs. PMA regulatory strategies.

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Investigational Device Exemptions
Holstein Howard
7/28/2011
Summary:

Paul Yock interviews Howard Holstein, regulatory attorney, on investigational device exemptions.

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Regulatory Case Studies
Holstein Howard
7/23/2011
Summary:

Paul Yock interviews Howard Holstein, regulatory attorney, discussing some regulatory case studies.

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Understanding the FDA
Holstein Howard
7/28/2011
Summary:

Paul Yock interviews Howard Holstein, regulatory attorney, on understanding the FDA.

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Assembling a Regulatory Team
Chong Su Mien
7/28/2011
Summary:

Paul Yock interviews Su-Mien Chong, regulatory consultant, on assembling a regulatory team.

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First Steps in the Regulatory Process
Chong Su Mien
10/23/2011
Summary:

Paul Yock interviews Su-Mien Chong, regulatory consultant, on assembling a regulatory team.

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Working with the FDA
Chong Su Mien
7/28/2011
Summary:

Paul Yock interviews Su-Mien Chong, regulatory consultant, to discuss working with the FDA.

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