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FDA issues draft guidance for VIP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Long awaited draft guidance for the Voluntary Improvement Program: https://www.fda.gov/media/158180/download  Let us know what you think (in addition to submitting your comments to the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

Measuring the Value Of Quality Webinar

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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.

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

CMMI

2HC Podcast episode 19: A conversation with Paul Kimmerly

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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.

CMMI

Two Harbors Consulting Podcast episode 18: The Interview

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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

CMMI

Podcast Episode 17: A bit of Implementation Infrastructure please

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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

CMMI

Cognosante Appraised at CMMI Level 3 for Service Delivery and Development

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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