FDA issues draft guidance for VIP

Long awaited draft guidance for the Voluntary Improvement Program: https://www.fda.gov/media/158180/download  Let us know what you think (in addition to submitting your comments to the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

Podcast Episode 17: A bit of Implementation Infrastructure please

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: [email protected] or at http://www.twoharborsconsulting.com. Tom Klein [email protected] George Zack [email protected] https://twoharborsconsultingpodcast.buzzsprout.com/976369/9236677-2hc-ep-17-a-bit-of-implementation-infrastructure-please

Cognosante Appraised at CMMI Level 3 for Service Delivery and Development

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

Episode 16 of the Two Harbors Consulting podcast – are there some practice areas in the CMMI more core than others?

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: [email protected]