Excited to see the announcement of enrollment for this program https://mdic.org/project/case-for-quality-accelerate-sustainable-capability-pilot/ from MDIC and the announcement from FDA: https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/accelerate-sustainable-capability-asc-pilot-study Let us know if you have any questions.
A brief webinar (22min) providing a very high level overview of some of the changes between CMMI 1.3 and 2.0 – https://www.youtube.com/watch?v=oh5kNP9JlW0
ISACA Chief Architect, Ron Lear and CMMC Board Member, Jeff Dalton join George Zack of Two Harbors Consulting to discuss the current state of CMMC, where it connects with CMMI and where it looks to be going in the future. We hope you find this conversation to be informative. https://twoharborsconsultingpodcast.buzzsprout.com/976369/4701203-2hc-ep-9-jeff-dalton-and-ron-lear-discuss-the-cmmc-and-cmmi Follow Ron at his CMMI Institute blog at: https://cmmiinstitute.com/news/blogFollow Jeff at his Linkedin at https://www.linkedin.com/in/jeffdalton/ or his Twitter at https://twitter.com/CMMIAppraiser
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
Ron Lear is our first guest on the podcast! Ron, ISACA’s Chief Architect and Director of IP Development at the CMMI Institute, shares a conversation with George Zack about CMMI 2.0, the future of the framework and its supporting tools, CMMC and other related topics. Let us know what you think of this episode. https://twoharborsconsultingpodcast.buzzsprout.com/976369/4331237-2hc-ep-8-a-conversation-with-isaca-s-chief-architect-and-director-of-ip-for-the-cmmi-framework-ron-lear
The Medical Device Discovery Appraisal Program. Got questions? Interested? Let us know. https://cmmiinstitute.com/getattachment/119c7189-a6c5-49a1-af39-7dc47669be6d/attachment.aspx
Episode 7 of the Two Harbors Consulting podcast. https://twoharborsconsultingpodcast.buzzsprout.com/976369/4229078-2hc-ep-7-going-off-the-script Becky, Tom and George had a topic to discuss but break from that script and speak to some aspects of process improvement that are more at their top of mind. Are 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 […]
The video recording of George Zack’s presentation at the Greenlight Guru Virtual Quality Summit https://www.youtube.com/watch?v=TGHlwwDv9BM Let us know if you have any follow up questions or other recommendations in considering these sort of engagements.
In the latest Two Harbors Consulting podcast (https://twoharborsconsultingpodcast.buzzsprout.com/976369/3984917-2hc-ep-6-considering-remote-audit-and-appraisal-activities) Becky and Tom ask George to discuss some of the lessons he has learned from performing some recent audit and appraisal work remotely (“virtually”) due to COVID19. What worked? What didn’t? George will be presenting more on this topic at the upcoming Greenlight Guru Virtual Quality Summit: Register for this fully free and fully virtual content packed Summit at https://virtual-summit.greenlight.guru/?sc=QVIW4uUc&ac=qbB2QCbS Two Harbors Consulting is proud to […]
Audits? Appraisals? Is there a difference? George, Becky and Tom of Two Harbors Consulting discuss the differences, similarities and value add of appraisals and audits. Is one better than the other? Can you get a map between the medical device quality system regulation (QSR) and the CMMI? Why aren’t their maturity levels used in the Case for Quality appraisal program? https://twoharborsconsultingpodcast.buzzsprout.com/976369/3676666-2hc-ep-5-appraisals-and-audits Also – check out 2HC at the upcoming Greenlight Guru Virtual Quality Summit: https://virtual-summit.greenlight.guru/?sc=QVIW4uUc&ac=qbB2QCbS Two Harbors Consulting is proud […]