Blog

January 29, 2023Podcasts, Webinars

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 […]

January 28, 2023Podcasts

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.

September 26, 2022September 26, 2022Case for Quality, CMMI, Improvement Tips, MDDAP, Podcasts

Episode 21 of the Two Harbors Consulting Podcast

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.

June 27, 2022Case for Quality, Case Study, CMMI, MDDAP, Presentations, Webinars

MDIC June 2022 Webinar re: the Case For Quality Voluntary Improvement Program

Recent presentations from stakeholders involved in the Case For Quality regarding the Voluntary Improvement Program. https://www.youtube.com/watch?v=3rn9NlWAt7w

May 5, 2022Case for Quality, CMMI, MDDAP

FDA issues draft guidance for VIP

Long awaited draft guidance for the Voluntary Improvement Program: https://www.fda.gov/media/158180/download Let us know what you think (in addition to submitting your comments to the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

May 4, 2022CMMI

ISACA / CMMI Institute Tech Talk regarding the performance report

An instructional video regarding the performance report from @CMMI_Institute

March 16, 2022Uncategorized

Greenlight Guru Global Medical Device Podcast on QSMR proposed rule

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

January 20, 2022Case for Quality, Webinars

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.

November 16, 2021Case for Quality, Case Study, CMMI, MDDAP

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

November 8, 2021November 8, 2021CMMI, Podcasts

2HC Podcast episode 19: A conversation with Paul Kimmerly

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.