FDA issues draft guidance for VIP

Long awaited draft guidance for the Voluntary Improvement Program: https://www.fda.gov/media/158180/download  Let us know what you think (in addition to submitting your comments to the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

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 […]

Episode 12 of the Two Harbors Consulting Podcast “You had an appraisal, now what?”

Next Two Harbors Consulting podcast is up – “You had an appraisal (or an audit) – now what?” https://twoharborsconsultingpodcast.buzzsprout.com/976369/6184336-2hc-ep-12-you-had-an-an-appraisal-now-what George is joined by Becky and Tom to discuss what happens after an organization has had an appraisal.    Now that you have results, what do should you do with those to get the most value of them? Are you enjoying this podcast?  If so, please share it with a colleague!  We’d love to have more people […]