A chat on CAPA with Naveen Aragwal

George was invited to converse with Naveen Argarwal on a recent post he put up on Linkedin about seatbelts.  They talk CAPA, risk management, quality culture, and leadership (to name a few!) https://youtu.be/DERVviyppL0 Naveen  is a thought leader in medical devices.  He seeks to  help medical device companies build safe products through compliant risk management processes that are also highly efficient and effective.  You can find him and information about his work, especially regarding risk […]

Two Harbors Consulting Podcast Episode 22

George, Tom and Becky start season 2 of the podcast.  https://twoharborsconsultingpodcast.buzzsprout.com/976369/12125111-2hc-ep-22-how-about-a-season-2 Let us know what performance improvement topics you’d like us to discuss, or let us know if you’d like to come join us.

FDA issues draft guidance for VIP

Long awaited draft guidance for the Voluntary Improvement Program: https://www.fda.gov/media/158180/download  Let us know what you think (in addition to submitting your comments to the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