Case for Quality

FDA issues draft guidance for VIP

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Long awaited draft guidance for the Voluntary Improvement Program: https://www.fda.gov/media/158180/download  Let us know what you think (in addition to submitting your comments to the docket). Kudos to all (you know who you are) that made this happen over the last handful of years. Thank you for your time, effort, and continuous improvement thinking.

Case for Quality

New case study for MDDAP

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A new case study posted by CMMI regarding the Medical Device Discovery Appraisal Program (@MDDAP) and the success Edwards Lifesciences has seen in the program. Let us know if you have any questions or want to discuss this innovative program. https://www.isaca.org/enterprise/medical-device-discovery-appraisal-program

Case for Quality

2HC Podcast Episode 13: A Conversation with Jon Speer

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We were very “stoked” to get a few minutes with Jon Speer of Greenlight Guru and to get his take on what we could expect to see in related to quality/regulatory in the medical device space in 2021. Hope you enjoy this episode of the Two Harbors Consulting podcast. https://twoharborsconsultingpodcast.buzzsprout.coI was very “stoked” to get a few minutes with Jon Speer of Greenlight Guru and to get his take on what we could expect to […]

Case for Quality

Episode 12 of the Two Harbors Consulting Podcast “You had an appraisal, now what?”

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Next Two Harbors Consulting podcast is up – “You had an appraisal (or an audit) – now what?” https://twoharborsconsultingpodcast.buzzsprout.com/976369/6184336-2hc-ep-12-you-had-an-an-appraisal-now-what George is joined by Becky and Tom to discuss what happens after an organization has had an appraisal.    Now that you have results, what do should you do with those to get the most value of them? Are you enjoying this podcast?  If so, please share it with a colleague!  We’d love to have more people […]

CMMI

Two Harbors Consulting Podcast Ep. 11 – Ask an Appraiser Anything October 2020 Webinar

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Episode 11 of the Two Harbors Consulting podcast – a recording of our “Ask an Appraiser Anything” October 2020 Webinar. Hope you enjoy it! https://twoharborsconsultingpodcast.buzzsprout.com/976369/5891494-2hc-ep-11-ask-an-appraiser-anything-october-2020-webinarEpisode 11 of the Two Harbors Consulting podcast – a recording of our “Ask an Appraiser Anything” October 2020 Webinar. Hope you enjoy it! https://twoharborsconsultingpodcast.buzzsprout.com/976369/5891494-2hc-ep-11-ask-an-appraiser-anything-october-2020-webinar

MDDAP

Recent Webinars on Case for Quality

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Miss any part of REDi?  Check it out at sbiaevents.com/redi2020/#files – in particular check out the latest on @caseforquality with an update from @CiscoVicenty from the @FDADeviceInfo at: concerted.adobeconnect.com/ps5q89fqn008/ – updates on @mddap, MDIAS, #makecapacool, Advanced Manufacturing and ASC. Looking for an update on the @MddaProgram? Be sure to checkout the @caseforquality session from @MDIConline with @CMMI_Institute ‘s @KimKaplan_US and @FDADeviceInfo @CiscoVicenty in this update:  https://www.youtube.com/watch?v=NcjaaixzWqg

Case for Quality

Celonova Case Study for MDDAP

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Read about how a regulated medical device manufacturer leveraged the CMMI Framework to reduce complaint cycle time. Let us know if you have questions or want to discuss further this innovative program! https://cmmiinstitute.com/getattachment/8069a72b-4d4f-491b-9739-ec6edb71e79a/attachment.aspx