Resources

• Choice of Business Entity: Pros & Cons of Corporations and LLCs
• LLC vs Inc: Pros & Cons
• Why a Startup Should Not Be an LLC
• 3 Reasons LLC May Be the Winner
• https://www.cooleygo.com/compare-business-entities-chart/

https://seed.nih.gov/sites/default/files/2024-04/Regulatory-Knowledge-Guide-for-Laboratory-Developed-Tests.pdf

General Regulatory Information: 

https://www.universitylabpartners.org/blog/navigating-regulatory-pathways-implications-for-medical-device-startups

De Novo:

https://dimesociety.org/wp-content/uploads/De-Novo-At-a-Glance_DiMe_RegPath.pdf

https://dimesociety.org/wp-content/uploads/De-Novo-Preparation-Guide_DiMe_RegPath.pdf

510(k): 

https://dimesociety.org/wp-content/uploads/510k-At-a-Glance_DiMe_RegPath.pdf

https://dimesociety.org/wp-content/uploads/510k-Preparation-Guide_DiMe_RegPath.pdf

PMA: 

https://dimesociety.org/wp-content/uploads/PMA-At-a-Glance_DiMe_RegPath.pdf

https://dimesociety.org/wp-content/uploads/PMA-Preparation-guide_DiMe_RegPath.pdf

HDE: 

https://dimesociety.org/wp-content/uploads/HDE-At-a-Glance_DiMe_RegPath.pdf

https://dimesociety.org/wp-content/uploads/HDE-Preparation-Guide_DiMe_RegPath.pd

https://seed.nih.gov/sites/default/files/2024-04/Regulatory-Knowledge-Guide-for-Cell-and-Gene-Therapies.pdf

NIH SBIR/STTR Programs: https://seed.nih.gov/

NSF SBIR/STTR: https://seedfund.nsf.gov/

DoD SBIR/STTR: https://www.dodsbirsttr.mil/submissions/login 

National Venture Capital Association: https://nvca.org/ 

Life Science Angels: https://www.lifescienceangels.com/ 

Y Combinator Start-up Library: https://www.ycombinator.com/library 

Cooley Go Start-up Resources: https://www.cooleygo.com/