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 […]
https://www.youtube.com/watch?v=2O3NAzfqiBg Check out this webinar that provides an introduction to the Accelerate Sustainable Capability pilot. Let me know if you have questions or are interested in possibly participating in the pilot.
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 […]
Excited to see the announcement of enrollment for this program https://mdic.org/project/case-for-quality-accelerate-sustainable-capability-pilot/ from MDIC and the announcement from FDA: https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/accelerate-sustainable-capability-asc-pilot-study Let us know if you have any questions.
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
The Medical Device Discovery Appraisal Program. Got questions? Interested? Let us know. https://cmmiinstitute.com/getattachment/119c7189-a6c5-49a1-af39-7dc47669be6d/attachment.aspx
The latest Case for Quality Forum sessions were recorded and the videos are posted now from MDIC: https://mdic.org/resource/case-for-quality-forum-march-12-2020/ There are sessions posted with updates from CMMI and CDRH. Let us know if you have any questions on any of the topics discussed at the Forum, or if you are interested in the Voluntary Improvement Program (also known as Medical Device Discovery Appraisal Program or MDDAP).