NEWS: (PORTLAND, Ore.) Paragon BioTeck, Inc., a privately held pharmaceutical and medical device company, announced today that it has received EN ISO 13485:2012 certification, signifying the company’s successful implementation of an effective quality management system.
The EN ISO 13485:2012 certification was awarded by the International Organization for Standardization, the world’s largest developer and publisher of global quality and safety standards. This certification outlines specific requirements to establish and execute a structured quality management system for medical devices across all areas, from development to supply.
“Achieving this certification is an important milestone for Paragon BioTeck,” said Lauren M-C Bluett, Director of Quality Assurance. “We have implemented a robust quality management system that conforms to ISO’s global standards, demonstrating our commitment to excellence in product and operations through continuous improvement and quality by design.”
Receipt of this certification paves the way for continued advancement of quality systems that meet world-class standards and maintain a central focus on patient safety and care.
About Paragon BioTeck, Inc.:
Paragon BioTeck, Inc., is a privately held pharmaceutical and medical device company specializing in the development and commercialization of ophthalmic pharmaceuticals, devices and therapies. Paragon BioTeck’s portfolio of products is designed to protect and preserve eyesight and deliver comfort to the eyes.
These products include the Comfortear(R) Lacrisolve(TM) 180 Absorbable Punctum Plug, Comfortear(R) Punctum Plug, EqualEyes(R) Ocular Lubricant, the preservative-free ilast(R) range of products and their FDA-approved Phenylephrine Hydrochloride Ophthalmic Solution USP, available in 2.5% and 10%.
For more information about Paragon BioTeck and its products, please visit http://www.paragonbioteck.com/.
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