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 […]
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.
It has been a minute but … Lynn Penn joined us for a few minutes to discuss some aspects of CMMI appraisal interviews. https://twoharborsconsultingpodcast.buzzsprout.com/976369/11387815-2hc-ep-21-mddap-interviews We’d love your feedback on this and what other topics you’d like to see covered in the ‘cast.
Recent presentations from stakeholders involved in the Case For Quality regarding the Voluntary Improvement Program. https://www.youtube.com/watch?v=3rn9NlWAt7w
Long awaited draft guidance for the Voluntary Improvement Program: https://www.fda.gov/media/158180/download Let us know what you think (in addition to submitting your comments to the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.
An instructional video regarding the performance report from @CMMI_Institute
Listen into the Greenlight Guru Global Medical Device Podcast where our own George Zack shares a conversation with Etienne Nichols, Mike Drues and Jon Speer on the proposed QSMR. https://www.greenlight.guru/blog/qmsr-future-of-fda-quality-management-system-regulation
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.
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
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.