The Case for Consiliso: Medical Device Company in a Box
What is Consiliso and why do you need it? This 150-page introduction to Consiliso’s integrated business process approach, specifically architected for the Medical Device Industry, explains it all. Geared towards company leaders, this quick read provides many examples of how Consiliso transforms your whole business, from product quality to clinical trials to finance. Available in paperback or e-book from Amazon.
What is Consiliso?
Since saying “engineered, integrated business processes for medical device companies” is rather a mouthful, we invented a new term. The Latin word consili, means “design.” The Greek word isos, means “equal.” The new term stands for the concept of designing, integrating and standardizing business processes across business systems. Specifically, Consiliso means designing for unity of process and standards across the varied aspects of running a business.
Consiliso is the first standard for how to design your business processes and information so it all works together. The result? A world-class Quality System and massive productivity improvements company-wide. It works just as well for start-ups as it does in multi-national corporations.
How is Consiliso Different from LEAN, SCRUM, Six Sigma, etc.?
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 needed 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 systems?
- 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.”
Coming soon—BLUEPRINT: Consiliso Subscription Services
In the coming months, Consiliso will launch “Consiliso Blueprint” a one-of-a-kind subscription service of real value to medical device companies. Inside this exclusive content zone, you will be able to:
- Access the most current updates to the textbook.
- Search our database of Laws, Regulations, Guidance and Standards to define your external requirements.
- Contact professionals and companies in the Medical Device field to further assist you.
- Download sample policy, process (including maps) and procedure documents.
- Explore the Consiliso-configured Agile PLM environment to see the architecture in action.
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