Two Harbors

We help organizations achieve greater business performance and quality results in regulated and compliance environments.

[Two Harbors @2HarborsConsult]

https://t.co/F3eXMgt9vb A couple of weeks back @georgezack had the opportunity to sit on an @MDIC panel regarding the @caseforquality @MddaProgram . Here is the recording from that. Let us know if you'd like this program. @CMMI_Institute @ISACANews

[Two Harbors @2HarborsConsult]

Some comments from Becky Fitzgerald @bltfitz at Two Harbors Consulting and Mark Rutkiewicz at @Innovize regarding their @MddaProgram case study including their initial involvement in the program's proof of concept. https://t.co/iF4N93MfuY @CMMI_Institute @caseforquality

[Two Harbors @2HarborsConsult]

Mark Rutkiewicz describes the value of internal ATMs on MDDAP appraisals. @MddaProgram @caseforquality @CMMI_Institute https://t.co/3i69cbgGwE

[Two Harbors @2HarborsConsult]

Two Harbors Consulting colleague Becky Fitzgerald @bltfitz answers the question what a CMMI Lead Appraiser is and what value they offer. https://t.co/Ia5NjX7qYK @CMMI_Institute @caseforquality @MddaProgram

[Two Harbors @2HarborsConsult]

ISACA recently published a "Tech Talk" on appraising the II and GOV PAs. https://t.co/6ROdL2ke1A

GOV is appraised in a fashion similar to II - or that it is considering an organization's processes, versus against the specific practices themselves.

[Two Harbors @2HarborsConsult]

Two Harbors Consulting Podcast Episode 23 - A conversation with Dr. Naveen Argarwal
https://t.co/otVfLN8Pyx

[Two Harbors @2HarborsConsult]

We start a season 2 so to speak on the 2 Harbors Consulting podcast. https://t.co/vqSVU6HowP Let us know what topics in performance improvement you want us to discuss (or even come join us)

[Two Harbors @2HarborsConsult]

Let us know if you have questions on this program.

https://t.co/EtcKd5eFHH

@caseforquality @MddaProgram @mddapvip

[Two Harbors @2HarborsConsult]

@caseforquality @MddaProgram

[MDIC @MDIConline]

MDIC Live with Case for Quality https://t.co/O3Q74NQvrd

[FDA Medical Devices @FDADeviceInfo]

Today, the @US_FDA issued the report: The Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings. https://t.co/ahSrM98Sbz

[Two Harbors @2HarborsConsult]

It has been a minute but ... Lynn Penn joined us for a few minutes to discuss some aspects of @CMMI_Institute appraisal interviews. https://t.co/2gc7mZCXfS
@caseforquality
@MddaProgram
We'd love your feedback on this and what other topics you'd like to see covered in the 'cast.

[Two Harbors @2HarborsConsult]

@georgezack provides input to this article regarding @caseforquality @MddaProgram. Let us know if you have any questions, input, or want to discuss further. https://t.co/kG2OWMRuPO @CMMI_Institute @FDADeviceInfo

[Two Harbors @2HarborsConsult]

Q&A with @KimKaplan_US from @CMMI_Institute regarding @MddaProgram https://t.co/uS6lOVPwFr

[Two Harbors @2HarborsConsult]

Day Two of the recent @MDIConline @caseforquality: https://t.co/VYdOBOJfC0 with interesting conversations related to metrics and their use from the @FDADeviceInfo, and both medical device and non medical device industry thought leaders.

[Two Harbors @2HarborsConsult]

Recent presentations from stakeholders involved in the @caseforquality For Quality regarding the Voluntary Improvement Program @MddaProgram . https://t.co/7H0SFrMQOd @FDADeviceInfo @ISACANews @CMMI_Institute

[Two Harbors @2HarborsConsult]

Kudos to @ShawnMSchmitt for collecting @CiscoVicenty and Steven Silverman, for a thought provoking conversation on compliance and quality. Anyone in the device space, especially the @MddaProgram / VIP or the @caseforquality should give it a listen. https://t.co/kIuozeVRxX

[Two Harbors @2HarborsConsult]

As part of the Quality Management Maturity (QMM) workshop last month, here is the @ISACANews presentation on successes using the @CMMI_Institute Model in the Voluntary Improvement Program with @FDAcdrhIndustry https://t.co/Pm5gx5wohS @MddaProgram @caseforquality

[Two Harbors @2HarborsConsult]

@MDIConline is asking for input to understand the impact of leadership engagement on company performance and the quality and safety of its products, regardless of industry.

Consider taking a few minutes to provide input to this survey: https://t.co/5DpK7IBqcV

[Two Harbors @2HarborsConsult]

Long awaited @caseforquality @MddaProgram draft guidance from the @FDAcdrhIndustry …https://t.co/OjoM5NJLst. Let us know your questions regarding this program.

[Two Harbors @2HarborsConsult]

An instructional video regarding the performance report from @CMMI_Institute https://t.co/tj0z3THsRh