QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices
FDA has proposed a new rule to align its Quality System Regulation (QSR) with ISO 13485:2016, the international standard for medical device quality management systems. How will, what's being referred to as Quality Management System Regulation (QMSR), affect the medical device industry and regulator…
2HC ep 11: Ask An Appraiser Anything October 2020 Webinar
In this episode, we share a recording of the October 2020 Two Harbors Consulting "Ask An Appraiser Anything" webinar. Lead Appraiser Tom Klein and George Zack of 2HC took questions on process improvement, the CMMI model, medical device regulation and approaches to appraisals. This was the first w…
2HC ep 21: MDDAP interviews
George is joined again by Lynn Penn (https://www.linkedin.com/in/mlpenn/) from Performance and Methods Consulting. They dive back into the CMMI appraisal interviews - specifically those for MDDAP appraisals: what makes for a good interview, what are some challenges, and how to be ready to manage …
2HC ep. 22 - How about a season 2?
Becky, Tom and George reconvene on this podcast after a year long break from it. They discuss what topics they see coming up in future episodes in this "season 2." What performance improvement topics do you want to see discussed? Are you enjoying this podcast? If so, please share it with a co…
2HC ep 24: consider CMMI and broader changes
Tom and George discuss an email that asked them about best practices for driving broader change from appraisals. They discuss some considerations to help process change stick.Are you enjoying this podcast? If so, please share it with a colleague! We'd love to have more people engage with us in t…
RM roundup #1: 10 of my favorite risk-related LinkedIn posts
Listen to my reading of a recent LinkedIn article I published to cover 10 of my favorite LinkedIn posts on risk-related topics. Listen to the recording and follow links below to read the original posts and continue the conversation.
🗞️A roundup of my favorite risk-related posts on LinkedIn!
1️⃣ Br…
RM roundup #3: 10 noteworthy risk-related LinkedIn posts
Listen to my reading of a recent LinkedIn article I published to cover 10 noteworthy risk-related posts recently published on LinkedIn. Listen to the recording and follow links below to read the original posts and continue the conversation.
🗞️A roundup of 10 noteworthy risk-related posts on LinkedI…
Muggsy Spanier- the Great 16
Classic sessions by Muggsy Spanier's Ragtime Band for Bluebird in 1939 - cornetist Spanier, George Brunies on trombone and vocal, Rod Cless on piano, George Zack and Joe Bushkin on piano, Bob Casey on Bass, Don Carter and Al Sidell on drums . . influential trad jazz!
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Muggsy Spanier - The Great 16, 1939
The Chicago cornetist Spanier had been playing with Ted Lewis for almost a decade before returning to the small group jazz fold with " . . His Ragtime Band" which played briefly in New York and made four sessions for Victor. With George Brunies on trombone, Rod Cless on clarinet, George Zack or Jo…
QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices
FDA has proposed a new rule to align its Quality System Regulation (QSR) with ISO 13485:2016, the international standard for medical device quality management systems. How will, what's being referred to as Quality Management System Regulation (QMSR), affect the medical device industry and regulator…
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