Category: MDDAP
Comments regarding the MDDAP proof of concept
Some comments from Becky Fitzgerald at Two Harbors Consulting and Mark Rutkiewicz at Innovize regarding their MDDAP case study including their initial involvement in the program’s proof of concept. https://www.youtube.com/watch?v=giyaCzPYPpQ
The Value of Internal ATMs on MDDAP appraisals
Mark Rutkiewicz describes the value of internal ATMs on MDDAP appraisals. @MddaProgram @caseforquality @CMMI_Institute https://www.youtube.com/watch?v=EjYIJwnSHew
Episode 21 of the Two Harbors Consulting Podcast
It has been a minute but … Lynn Penn joined us for a few minutes to discuss some aspects of CMMI appraisal interviews. https://twoharborsconsultingpodcast.buzzsprout.com/976369/11387815-2hc-ep-21-mddap-interviews We’d love your feedback on this and what other topics you’d like to see covered in the ‘cast.
MDIC June 2022 Webinar re: the Case For Quality Voluntary Improvement Program
Recent presentations from stakeholders involved in the Case For Quality regarding the Voluntary Improvement Program. https://www.youtube.com/watch?v=3rn9NlWAt7w
FDA issues draft guidance for VIP
Long awaited draft guidance for the Voluntary Improvement Program: https://www.fda.gov/media/158180/download Let us know what you think (in addition to submitting your comments to the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.
New case study for MDDAP
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
Discussion on the Case for Quality with Gabor Szabo
George Zack sat down with Gabor Szabo for a chat on the Case for Quality on the Critical Talks podcast.
2HC Podcast Episode 13: A Conversation with Jon Speer
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 […]
Episode 12 of the Two Harbors Consulting Podcast “You had an appraisal, now what?”
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 […]
