Mark Rutkiewicz

After 30 years in the industry, Mark Rutkiewicz is well known for fixing Quality Systems in all sizes and types of medical device companies. And even more known for moving beyond compliance-focused functions and fixing all the other business process and information sharing issues across the company.

Ask your people these questions:

How much time do you spend just looking for the information they need to do your job?

Are you often stymied by your company bureaucracy?

Do the product line definitions in R&D match the ones in the DHF, the regulatory submissions, as well as the PLM, ERP and the complaints system?

Are there duplicate business processes for compliance to ISO 9001 (General Quality System), ISO 13485 (Medical Device Quality System), FDA 820, ISO 14001 (Environmental), ISO 45001 (Health & Safety) ISO 14155 (Clinical) and the FDA regulations for conducting clinical trials? If so, why?

If you are not following the principles of integrated business process design--the core concept of Consiliso--you probably will not like the answers you receive to these questions. Particularly if your product line definitions don't match across the company--that means you are working way too hard to track and trend for compliance, sales performance and continuous improvement efforts.

If you want the solutions--the nitty gritty "how to" make everything work together seamlessly--then you need Consiliso. Start with the overview "Medical Device Company in a Box" and then move on to the textbook, "Consiliso: The Blueprint."

Learn more at consiliso.com