FDA issues draft guidance for VIP

Long awaited draft guidance for the Voluntary Improvement Program: https://www.fda.gov/media/158180/download  Let us know what you think (in addition to submitting your comments to the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

Measuring the Value Of Quality Webinar

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.

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: 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