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Long awaited draft guidance for the Voluntary Improvement Program: https://www.fda.gov/media/158180/download Let us know what you think (in addition to submitting your comments to the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.
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
Here is the video from the panel that @georgezack participated in as part of @MDIConline ‘s @caseforquality Forum last week. https://youtu.be/ppBbXxZ8tKc We’d love your feedback and happy to discuss any questions you have.
MDIC released it Leadership Engagement Playbook today to help organizations move their companies from a culture of compliance to one focused on quality and continuous improvement. We were happy to contribute to this effort and look forward to your questions and feedback. http://www2.mdic.org/webmail/673283/508019307/76ce0f7e0844b82419ecbbe5d067e134c0f0e040de3ef5415e62a4dc37e63eec
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.