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Home > Voices In Validation > Part 3 of Get Your Medical Device to Market in 10 Easy Steps: Product Launch
Podcast: Voices In Validation
Episode:

Part 3 of Get Your Medical Device to Market in 10 Easy Steps: Product Launch
Category: Science & Medicine
Duration: 00:44:50
Publish Date: 2019-12-24 05:00:00
Description:

On today’s episode, Stacey Bruzzese welcomes Roberta Good, the founder of Goode Compliance for the final part of our 3-part series.  Stacey and Roberta review the steps necessary for a successful product launch.

Stacey and Roberta cover a variety of topics:

  • Roberta outlines the steps associated with the final phase prior to product launch
  • Do you still need to be thinking about verification and validation?
  • Is this the right time to be thinking about marketing and branding?
  • What data are you looking for with a product release into Limited Test Markets or Clinical Trial Sites?
  • How thorough should your completed technical documentation need to be prior to full product launch?
  • Roberta reviews all that is needed to fully launch the product
  • What does the post-market surveillance entail and how long does it take to complete?
  • What are the best practices for capturing this data?
  • How does cloud-based computing affect the requirement for maintaining post-market data integrity?
  • What kinds of problems could occur after product launch?
  • Roberta talks about how listeners can make use of the information presented in this 3-part series

The following links have useful companion information for this episode:

Post-Market Requirements:

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/postmarket-requirements-devices

IVT’s Medical Device Validation Handbook:

http://www.ivtnetwork.com/article/medical-device-validation-handbook

Twice awarded IVT’s Speaker of the Year, Roberta Goode is the founder of Goode Compliance, where she created over 350 jobs, forming an astonishingly talented team of biomedical engineers.  After she and her team remediated enforcement actions for 17 of the world’s 20 largest medical device manufacturers, Roberta turned her attention to sharing that wealth of accumulated knowledge.  In 2018, she founded Altrec, LLC to lead paradigm-shifting programs including CDRH’s Benefit-Risk Collaborative Community, and to provide custom technical training and mentoring to the medical device industry.   

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
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