Barile Consulting Services, LLC, creates a lean model and lowers the cost of their ISO 13485 Consulting for Medical Equipment Suppliers.

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Many Companies that want to grow their business as a medical equipment supplier recognize the need for ISO 13485 certification and an expert consultant to implement the quality management system. Barile Consulting Services, LLC, has experience in solving the unique problems faced when implementing ISO 13485 systems for Medical suppliers. Their new business model allows Barile Consulting Services, LLC, the ability to offer ISO Consulting at up to 50% less than their competitors.

Our business model allows Barile Consulting Services, LLC to offer expert ISO consulting to our clients at up to 50% less than our competitors.

Many large medical manufacturers require their suppliers to implement ISO 13485 within their organization. Without ISO 13485 certification these companies may not even be able to quote on projects offered by major manufacturers.

ISO 13485, recognized internationally, is a Quality Management System for manufacturers of medical devices. This standard is based off ISO 9001 and includes additional requirements within the medical industry.

Medical suppliers can use their ISO 13485 system as an effective marketing tool to gain new customers and also as a model to run all aspects of their business with more efficiency and less waste.

“Barile Consulting Services, LLC, understands that efficiency, low implementation costs, and easy maintenance of the ISO 13485 system are critical in delivering value to the client seeking certification.” Said David Barile, one of the most experienced ISO 13485 and ISO 9001 Consultants in the Midwest. Barile Consulting Services, LLC, specializes in helping companies obtain ISO 13485 and ISO 9001 Certification.

Creating an effective ISO 13485 manual so that employees can be certain they are adhering to the requirements of the quality management system is very important. An annual audit is also extremely important to determine compliance with the system and that certification is maintained. Barile Consulting Services, LLC, provides all of their clients with an annual audit to ensure ISO 13485 compliance.

Implementing ISO 13485 with the assistance of large consulting firms will be very costly. Not only will the initial implementation costs be high, but it will be costly as well to maintaining such a bloated system. Barile Consulting Services, LLC, is a small consulting firm located in Cleveland, Ohio. Barile Consulting Services, LLC, is now able to offer ISO consulting at up to 50% less than their larger competitors.


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