Long awaited draft guidance for the Voluntary Improvement Program: https://www.fda.gov/media/158180/download Let us know what you think (in addition to submitting your comments to the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.
An instructional video regarding the performance report from @CMMI_Institute
Listen into the Greenlight Guru Global Medical Device Podcast where our own George Zack shares a conversation with Etienne Nichols, Mike Drues and Jon Speer on the proposed QSMR. https://www.greenlight.guru/blog/qmsr-future-of-fda-quality-management-system-regulation
Members of Medical Device Innovation Consortium (MDIC)‘s Leadership Engagement Team interviewed Milan Shah from Biofourmis for the case study for Measuring Value of Quality, covering how the value of quality is measured, what is done reactively and what is done proactively, through the journey of the integration and harmonization QMS for global product launches.
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
Becky and George sit down with Paul Kimmerly as our guest where discuss the ATL observation process (using George’s recent one as the context example). https://twoharborsconsultingpodcast.buzzsprout.com/976369/9493959-2hc-ep-19-paul-kimmerly-and-the-lead-appraiser-observation-process If you are up for it, give it a listen and let us know what you think.
Two Harbors Consulting podcast with @TomKlein and @GeorgeZack on “the interview” – we discuss why there are appraisal interviews, how to prepare for them (or not), and how to get value out of them. https://twoharborsconsultingpodcast.buzzsprout.com/976369/9350710-2hc-ep-18-the-interview
George and Tom continue a dive into the CMMI model as they discuss the Implementation Infrastructure practice area. Let us know what you think. What questions, challenges or success stories do you have? What other process improvement or regulatory topics you’d like to have covered in future podcasts? Contact us at: info@twohc.com or at http://www.twoharborsconsulting.com. Tom Klein tom.klein@twohc.com George Zack george.zack@twohc.com https://twoharborsconsultingpodcast.buzzsprout.com/976369/9236677-2hc-ep-17-a-bit-of-implementation-infrastructure-please
We were happy to recently partner with Cognosante with their multi model appraisal, where they achieved a CMMI Level 3 rating for both the Development and Service views of the Model. https://www.wfmz.com/news/pr_newswire/pr_newswire_health/cognosante-appraised-at-cmmi-level-3-for-service-delivery-and-development/article_576c91be-a6c4-5027-b822-7641c9644bba.html
In this episode of the Two Harbors Consulting podcast: Becky, Tom and GZ muse on which practice areas within the CMMI model might have greater importance than others: https://twoharborsconsultingpodcast.buzzsprout.com/976369/8797457-2hc-ep-16-are-there-core-practice-areas-in-the-cmmi-model Let us know what you think. What questions, challenges or success stories do you have? What other process improvement or regulatory topics you’d like to have covered in future podcasts? Contact us at: info@twohc.com
