What Does CMMI, the FDA and Your Organization’s Maturity Have In Common?

When:  Aug 13, 2025 from 06:00 PM to 08:00 PM (CT)
Associated with  Medical Device Division

What is maturity, when applied to a company? Simply, it is a quantifiable measure of how consistently and efficiently a company operates, and how well it can identify and meet its key process metrics.

In 2011, the FDA launched its Case for Quality.  They saw that just being compliant with the Quality System Regulations (QSR) did not make companies produce better products.   The FDA worked with Medical Alley to create a new public-private partnership so the FDA could work directly with industry.  The FDA’s Voluntary Improvement Program (VIP), launched in 2018, is a way to assess your organization’s maturity to industry best practices while getting some preferential treatment by the FDA.  The VIP program leverages the Capability Maturity Model for Integration (CMMI) model and lets you tailor the assessments to where you need help the most.

Join in the discussion with Mark as he reviews:

·         The history of MDIC

·         The history of CMMI

·         Organizational maturity concepts

·         The FDA VIP program and benefits

·         Effects of the new QMSR

·         Case studies

Who should attend?  Individuals who want to promote continuous quality improvement beyond regulatory compliance.

Venue: Online. A Zoom link will be sent to all registrants closer to the event date.

Date: Tuesday, August 13, 2025

Time:  6:00 pm to 8:00 pm CST

Cost

  • ASQ Members $15

  • Non-Members $25

  • Students, $10 when registering with your valid, current school email.

  • Groups of 5 or more will receive the Member rate.

Certificates of CompletionIssued via email, after event completion, for .2 ASQ RUs or .2 CEUs

Please contact Karen Peifer, Committee Chair, at asqmnbmc@gmail.com if you have any questions.

Your Speaker

Mark Rutkiewicz, Consiliso, LLC

For over 35 years, Mark Rutkiewicz has led Quality organizations and has managed company business processes in six medical device companies.  He has designed Quality Management Systems for active and non-active implantables, disposables, combo devices, software and capital systems.  Mark built and rebuilt online integrated corporate-wide quality/business systems.  He has a Bachelor of Electrical Engineering from the University of Minnesota and a Masters of Applied Liberal Studies from Hamline University.  Mark retired in 2024, but started his own consulting company Consiliso LLC.  Mark is the author of two books on Consiliso, which define how to create reconfigurable organizations and implement integrated business processes.  He led efforts for the MDIC’s Case for Quality (CfQ) Voluntary Improvement Program (VIP) and is involved in the MDIC Safe Space program. 

Sponsor Information

The MN ASQ Biomedical Consortium (BMC) is a group of quality professionals promoting and advancing quality tools, principles, and practices through educational events.  We focus on the medical device industry but promote events for other regulated environments. 

·      Follow us on LinkedIn to stay informed of upcoming events:  https://www.linkedin.com/showcase/90642322/

To become a member of the MN ASQ Biomedical Consortium, please contact Karen Peifer, Committee Chair or Sahi Datla, Committee Co-Chair, at asqmnbmc@gmail.com.

The American Society for Quality (ASQ), is a knowledge-based global community of quality professionals, with nearly 80,000 members dedicated to promoting and advancing quality tools, principles, and practices in their workplaces and communities.  As your career partner, ASQ membership benefits are designed to help meet your growing needs as a quality professional.  Membership provides exclusive access to quality knowledge, solutions, and resources to solve challenges, and skill development to advance your career. ASQ is committed to providing enhanced expertise, professional networks, tools, and solutions to help our members advance their products, services, and industries.

ASQ:  https://www.asq.org/ 

Location

Online Instructions:
Url: https://mp.gg/zzovbabefn
Login: Registrants will receive instructions on how to receive the Zoom link closer to the event.
Event Image
Download to Your Calendar Outlook Google

Contact

Karen Peifer

kpeifer@mnasq.org