Each Iteration is a Step toward Higher Quality

Innovize is committed to continuous quality improvement, in the management of our own operations and in the projects and processes deployed for our clients. We listen to requirements, deliver on commitments and seek to streamline processes by eliminating non-value-added steps.

Our quality policy states: “We are committed to providing products that meet or exceed quality and regulatory requirements by continually improving the effectiveness of our Quality System through process improvement.”

Innovize uses the medical device industry’s first blueprint for medical device company quality system architecture.  This blueprint is defined in the Consiliso textbook written by our Vice President of Quality, Mark Rutkiewicz.  Mark’s two books on this Consiliso architecture provide industry best practices for all types of medical device companies. www.consiliso.com

Download Our Industry Leading Quality System eBook

Lean, Clean, Certified and Compliant

With Innovize, you’ll find:

  • Case for Quality – CMMI MDDAP Assessed
  • Clean-room/ dry-room environments
  • Lean manufacturing
  • UL-approved labels
  • Consiliso Compliant

Innovize and CMMI Partnership with the FDA

In 2015, Innovize’s VP of Quality (Mark Rutkiewicz) joined the small team to implement the maturity model assessment concept. The CfQ project had chosen the CMMI Institute’s model which is called the Capability Maturity Model Integration (CMMI).

With Mark’s 30 years of experience building and rebuilding Quality Systems in all size medical device companies, Mark took on the leadership of the Maturity Model implementation sub team. The first challenge was to get the FDA to agree the CMMI assessment would work, so Mark volunteered Innovize to be the Proof of Concept. Innovize had just passed an FDA QSIT inspection in January of 2016 with no findings. This is a pre-requisite for the CMMI assessment. In June of 2015, this two-day assessment was done at Innovize with the FDA watching the entire interaction over a video feed. The FDA was pleased with the process and it was agreed that a larger pilot was needed.

Quality Compliance

In August of 2017, the FDA formally launched an industry-wide pilot program.  Innovize was the first company to sign up.  Innovize had their first full assessment to CMMI Level 2 under the program in December 2017 and a second assessment to CMMI Level 3 in December of 2018.

Case for Quality Maturity Assessments – Innovize Leads the Industry

Innovize led the way for “The Voluntary Manufacturing and Product Quality Program Results.”

This program is expected to be formally adopted by the FDA in 2020.

To sign up for this FDA program, a company needs to be in good standing with the FDA.

The biggest benefit to the industry and customers working with these companies is that they don’t just pass minimum FDA standards, they also have a culture of high quality and continuous improvement!

Benefits of CMMI Model:

  • Standard FDA inspections are not required
  • 510K 30-day notice (approved in 2 days)
  • Pre-Market approval inspections waived
  • Manufacturing site transfer inspections waived