Uncategorized

February 4, 2023February 4, 2023Uncategorized

Two Harbors Consulting Podcast Episode 23, A conversation with Dr. Naveen Argarwal

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://twoharborsconsultingpodcast.buzzsprout.com/976369/12136553-2hc-ep-23-a-conversation-with-naveen-agarwal Dr. Naveen Agarwal has 20+ years of diverse industry experience in leadership roles ranging from R&D to Product Quality and Business Analytics. He holds a Ph.D. in Polymer Science & Engineering from the University of Massachusetts, Amherst. He is an ASQ certified […]

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

December 23, 2020December 23, 2020Case for Quality, CMMI, MDDAP, Podcasts, Uncategorized

2HC Podcast Episode 13: A Conversation with Jon Speer

We were very “stoked” to get a few minutes with Jon Speer of Greenlight Guru and to get his take on what we could expect to see in related to quality/regulatory in the medical device space in 2021. Hope you enjoy this episode of the Two Harbors Consulting podcast. https://twoharborsconsultingpodcast.buzzsprout.coI was very “stoked” to get a few minutes with Jon Speer of Greenlight Guru and to get his take on what we could expect to […]

October 7, 2020Uncategorized

Case for Quality becomes a Collaborative Community

Case for Quality becomes a Collaborative Community Announcement. Case for Quality becomes a collaborative community with FDA – @MddaProgram @caseforquality https://www.businesswire.com/news/home/20201007005846/en/The-Medical-Device-Innovation-Consortium-MDIC-Announces-Case-for-Quality-Collaborative-Community-with-FDA-Participation

July 17, 2020July 17, 2020Case for Quality, Case Study, MDDAP, Uncategorized

Celonova Case Study for MDDAP

Read about how a regulated medical device manufacturer leveraged the CMMI Framework to reduce complaint cycle time. Let us know if you have questions or want to discuss further this innovative program! https://cmmiinstitute.com/getattachment/8069a72b-4d4f-491b-9739-ec6edb71e79a/attachment.aspx

June 4, 2020Uncategorized

Remote audits and appraisals in a COVID19 world

The video recording of George Zack’s presentation at the Greenlight Guru Virtual Quality Summit https://www.youtube.com/watch?v=TGHlwwDv9BM Let us know if you have any follow up questions or other recommendations in considering these sort of engagements.

March 10, 2020Uncategorized

Why Two Harbors?

February 18, 2020Uncategorized

Updates on the Case For Quality

From the tail of last year, but insightful related to the direction for some of the elements of the Case for Quality. https://www.youtube.com/watch?v=pIvLWQbrTcY&feature=youtu.be

December 28, 2019Uncategorized

Case for Quality Voluntary Improvement Program (also known as the Medical Device Discovery Appraisal Program) white paper

The CMMI Institute has published the FDA written white paper that describes the state of the MDDAP pilot program through September of 2019. Read / download it here: https://cmmiinstitute.com/getattachment/9f083064-60a1-4d2a-be58-3602f60d154f/attachment.aspx

October 5, 2019Uncategorized

Annual Public Forum recordings are up

MDIC Annual Public Forum session recordings are up. https://lnkd.in/eDnyQV2