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RCRI IS ISO 9001:2000 CERTIFIED
October 2007
RCRI receives ISO 9001:2000 Re-certification
RCRI was approved for ISO 9001:2000 re-certification on October 8, 2007
January 2005
Regulatory & Clinical Research Institute, Inc. Receives ISO 9001:2000 Certification
Certification assures customers that its services meet the most current worldwide quality standards.
MINNEAPOLIS, MN – January 21, 2005 – Regulatory & Clinical Research Institute, Inc. (RCRI)®, a leading provider of consulting services to the medical devices, IVD, and biosciences industries, announced today that it has received ISO 9001:2000 certification.
“We are committed to maintaining our quality systems at the highest available standards. ISO 9001:2000 certification assures our clients that we are providing high quality services,” said Steve Norsted, Ph.D., president and chief executive officer of RCRI.
The ISO 9001:2000 standards, released in December 2000 as the successor to ISO 9000:1994, is an internationally recognized quality management system (QMS) standard developed by the ISO (International Organization for Standardization). “To meet the registration requirements, companies must implement and document QMS processes involving staff training, product design and processes, materials and services purchasing, and product service delivery,” said Jennifer Marrone, executive vice president of RCRI. ISO is a network of national standards institutes from more than 140 countries working in partnership with international organizations, governments, industry, business and consumer representatives.
RCRI is a leader in providing integrated CRO services to the medical devices, IVD, and biosciences industries. The company’s expert services include: regulatory affairs; clinical trial design and management; biostatistics; reimbursement and healthcare economics; quality systems and compliance; preclinical services; and venture capital due diligence.
Since its inception in 1999, RCRI has helped more than 180 companies worldwide take products from concept to market. Clients have ranged from development stage start-ups to Fortune 50 companies. RCRI has worked in a wide range of medical specialties and has developed particular expertise in cardiovascular, interventional cardiology, neurology, orthopedic, urology and wound healing products among others. Its staff of highly qualified professionals with backgrounds in industry, academia, and government has a proven track record of transitioning concepts and prototypes into successful commercially released products.
No matter the size of the company or the complexity of the project, RCRI is dedicating to serving clients with knowledge, integrity, and ingenuity.
For more information about RCRI®’s services, visit the Web site at http://www.rcri-inc.com/.
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© Copyright 2008 Regulatory & Clinical
Research Institute. All rights reserved.
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