Episode Synopsis "2HC ep 13: A Conversation with Jon Speer from Greenlight Guru"

George is joined by the president of regulatory and quality at Greenlight Guru and the host of the Global Medical Device podcast Jon Speer.  Jon gives some of his insights as to what will be hot topics in the quality/regulatory world in 2021.Some reference links:The latest on the QSR migration to 13485 https://medtech.pharmaintelligence.informa.com/MT143243/FDA-Picks-New-Target-Date-For-Releasing-Its-Draft-Harmonized-Quality-System-RegulationThe Payor pilot:https://www.fda.gov/about-fda/cdrh-innovation/payor-communication-task-forceGreenlight Guru:https://www.greenlight.guru/The Global Medical Device Podcast:https://www.greenlight.guru/podcastsAre you enjoying this podcast?  If so, please share it with a colleague!  We'd love to have more people engage with us in these conversations.  And we always want your feedback about any element of podcast.  Contact us at: [email protected] or at http://www.twoharborsconsulting.com or George Zack at [email protected]

Listen "2HC ep 13: A Conversation with Jon Speer from Greenlight Guru"

More episodes of the podcast Two Harbors Consulting Podcast

• 2HC ep 25: DAR (the Decision Analysis Resolution practice area from the CMMI Model)
• 2HC ep 24: consider CMMI and broader changes
• 2HC ep 23: A conversation with Naveen Agarwal
• 2HC ep. 22 - How about a season 2?
• 2HC ep 21: MDDAP interviews
• 2HC ep 20: Where do medical device regulations and the CMMI intersect? A conversation with Beth Layman.
• 2HC ep 19: Paul Kimmerly and the lead appraiser observation process
• 2HC ep 18: The Interview
• 2HC ep 17: A bit of Implementation Infrastructure please
• 2HC ep 16: Are there core practice areas in the CMMI model?
• 2HC ep 15: Where has the 2HC podcast been?!
• 2HC ep 14: revisiting size and estimation
• 2HC ep 13: A Conversation with Jon Speer from Greenlight Guru
• 2HC ep 12: You had an an appraisal, now what?
• 2HC ep 11: Ask An Appraiser Anything October 2020 Webinar
• 2HC ep 10: A conversation with Lynn Penn
• 2HC ep 9: Jeff Dalton and Ron Lear discuss the CMMC and CMMI
• 2HC ep 8: A conversation with ISACA's Chief Architect and Director of IP for the CMMI Framework, Ron Lear
• 2HC ep 7: Going off the script
• 2HC ep 6: Considering remote audit and appraisal activities
• 2HC ep 5: Appraisals and Audits
• 2HC ep 4: You signed up for a CMMI appraisal! Now what?
• 2HC ep 3: attributes of an effective measure
• 2HC ep 2: what is this estimation thing anyway?
• 2HC ep. 1: Considering requirements beyond the product