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Microbiologics Receives ISO 13485 Certification

Global leading producer of prepared microorganisms for quality control testing, Microbiologics, Inc., has received ISO 13485: 2003 certification. International Organization for Standardization (ISO) 13485: 2003, Medical devices - Quality management systems - Requirements for regulatory purposes, is the principal standard for manufacturers of medical products, devices and components. BSI is the accrediting body that certified Microbiologics to the ISO 13485 standard.

Microbiologics Senior Quality Systems Manager, Tina Sobania, commented, “Achieving certification to the ISO 13485 standard is a testament to Microbiologics’ Quality Management System and our ability to consistently design, develop, produce and distribute in-vitro microorganism preparations of the highest quality.” Sobania added, “We have an extensive network of over 140 distributor partners throughout the world; adding this certification to our list of credentials will allow us to continue to expand in the global marketplace.”

Established in 1941, Microbiologics has been producing commercial ready-to-use quality control microorganism preparations for more than 40 years. With a product portfolio of more than 800 different microorganism strains which are manufactured in 16 distinct formats, including both qualitative and quantitative configurations, Microbiologics has the largest and most diverse line of QC microorganism products in the market.

Brad Goskowicz, Microbiologics Chief Executive Officer, stated, “I am very proud of Microbiologics’ latest accomplishment of receiving ISO 13485 certification. It further illustrates the exceptional capabilities we have as a company to maintain an exemplary Quality Management System and produce products that meet even the most stringent of standards.” Goskowicz continued, “Our international business continues to grow and this certification will be a great asset as regulatory requirements continue to expand globally and additional emphasis is placed on supply chain management.”

About Microbiologics:

Microbiologics manufactures cost‐effective, reliable, and easy-to-use microorganism preparations for Quality Control testing in microbiology laboratories across multiple disciplines including clinical, food, pharmaceutical and cosmetic, medical device, water and environmental. Microbiologics is an FDA registered establishment and has received ISO 9001 and ISO 13485 certification, as well as ISO 17025 and ISO Guide 34 accreditations. Currently, Microbiologics has an international distribution network of over 140 companies throughout the world.

For additional information, please contact Customer Service at (320) 253-7400, email or visit


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