Textbook for Medical Device Makers

Industry standardization resource for best practices has arrived!  Consiliso:  The Blueprint for Integrating Business Processes in Medical Device Companies was written after 30 years of leadership experience in the medical device industry by Mark Rutkiewicz–Innovize,Vice President of Quality.  Mark has distilled all his “how to” knowledge down to this 472 page manual, available now.

Most other books in this space present and expand upon one or two concepts (like how to improve your CAPAs, or audits, or submissions) but Consiliso covers literally every activity your business performs, whether you make bandages, implantable devices, accessories, capital systems, combo products or any other kind of device.

For more information –

https://www.consiliso.com/the-textbook-for-medical-device-makers-has-arrived/

Mark Rutkiewicz, Consiliso Founder

We will be at MD&M East!

You’ve got a product.

We’re here to help you make it better.

Find us in Booth #756 at MD&M East.

We are eager to listen to your story.

Mark Rutkiewicz speaks at CMMI Institute

Mark Rutkiewicz (2^nd from left) shares his experience as an early adopter of the Medical Device Discovery Appraisal Program at CMMI Institute’s Capability Counts 2018 event.

Mark is Vice President of Quality at Innovize and Founder of Consiliso LLC.

For more information about Innovize’ participation in the FDA’s Case for Quality contact Mark at info@innovize.com

Mark Rutkiewicz speaks at MDTX

Our VP of Quality, Mark Rutkiewicz, was a presenter at the Medical Device Technology Exchange conference in New Jersey in April, 2018.

A white paper written by Mark on the subject of his presentation can be found here https://www.innovize.com/why-work-with-us/white-papers/

Let’s do business in Boston April 18-19, 2018

Innovize has been improving people’s lives for 60 years.   Stop by our booth #736 while at the BIOMEDevice show.   Our experienced business development team is waiting to partner with you to improve your project and your life.

While at the show, we invite you to hear our VP of Quality, Mark Rutkiewicz speak on Thursday at 2 pm as he presents a Case for Quality:  Implementing the Medical Device Company Maturity Model.

The Medical Device Innovation Consortium (MDIC) is driving quality improvements for medical device companies through the Case for Quality (CfQ) project, specifically developing a maturity model assessment for the industry. In July 2017, FDA introduced the Medical Device Discovery Appraisal Program (MDDAP) and is now offering regulatory incentives to sign-up for the program. Innovize is one of the first companies to go through pilot assessments.

https://www.innovize.com/why-work-with-us/quality-continuous-improvement/

Join Innovize & Mark Rutkiewicz at new MDTX conference in April 2018

Innovize will be exhibiting in Booth 311 so plan to stop by and ask us about our capabilities. Our experienced team looks forward to learning about your current needs.

Innovize VP of Quality, Mark Rutkiewicz, will be presenting “5 Key Questions to Determine if That Contract Manufacturer is a Good Fit for You” at the 2018 MDTX New York conference on Thursday, April 5 from 10:30am – 10:55 am.

An interview: VP of Quality talks about role with FDA’s Case for Quality

Mark Rutkiewicz, VP of Quality at Innovize, was recently interviewed about his role on the FDA’s Case for Quality program.  Click on the link below to read the entire interview and learn how this new program can save companies time and money.

MD+DI interview with Mark Rutkiewicz

Our first time at ADM Cleveland!

Stop by booth #925 to talk with us about your project at any stage.

See you March 7 & 8, 2018 at the Huntington Convention Center of Cleveland.

Anaheim – here we come!

We will be back in our same location, Booth #1632, from February 6-8, 2018 for the MD&M West Expo at the Anaheim Convention Center.

Stop by our booth #1632 and tell us about your current needs.

Our experienced Sales Team will be on hand to discuss your ideas at any stage.

Quality System Book Launch

Innovize is excited to announce that our Vice President of Quality, Mark Rutkiewicz is launching two books specifically targeted for medical device company Quality System and company-wide compliant, efficient business process design. 

 Medical Device Company in a Box—The Case for Consiliso

 And the upcoming textbook:

 Consiliso: The Art of Integrating Engineered Business Processes in Medical Device Companies

Innovize celebrated Mark’s accomplishment at the recent MD&M Minneapolis tradeshow and at a book signing party.

Congratulations Mark!