5 FDA Myths for Start-Ups with Justin Bushko
Start-Ups are really doing great to develop the Medical Devices that patient needs but they should satisfy Investors and also Regulators. This can create some situations.
This is why Justin Bushko will share with us his experience with Start-Ups by listing 5 FDA Myths. I am sure you’ll recognize some of them as maybe your company experienced that.
At the end of the show notes, I will also provide you a link to download a document that summaries our discussion with Justin. This can be helpful if you want to teach your team about some of them.
Who is Justin Bushko
Justin Bushko, Principal of Concise ENGINEERING, holds a BS in Electrical Engineering from Grove City College and an MBA in Leadership & Management from the University of South Florida. CONCISE offers support in Program & Project Management, Electrical Product Safety and Usability in the Medical Device Industry.
Concise also offers support to Start-Ups focused on the development of embedded systems. Justin has provided New Product Development solutions to industry for the last 20 years. He has led design teams to launch or sustain over 100 products.
Additional certificates include Project Management Professional (PMP), ASQ Software Quality Engineer, Six Sigma Black Belt, Design for Six Sigma, Lean Design, Kaizen and Root Cause Analysis.
Links
- Justin Bushko Linkedin: https://www.linkedin.com/in/bushkojustin/
- Concise Engineering Website: https://www.concise-engineering.com
- FDA registration with Michelle Lott: https://podcast.easymedicaldevice.com/43
- Cheat Sheet document to download: https://mailchi.mp/easymedicaldevice/episode-45
