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SANYO Commercial Solutions, Biomedical Division receives ISO 13485 Certification for Biomedical Equipment

"The ISO13485 certification covers the following preservation product lines: MDF, MPR, MBR and incubation product lines: MCO, MIR, MLR, MCOK. "

 



(EMAILWIRE.COM, June 20, 2008 ) Wood Dale, IL — SANYO Electric Biomedical Division received ISO 13485 certification for the design and manufacturing of medical equipment.

ISO 13485 certifies:
•an organization consistently demonstrates its ability to provide medical devices and related services that meet both customer expectations and regulatory requirements
•there are controls in the work environment to ensure product safety
•risk management activities are implemented during product development
•Specific requirements are set for the verification of corrective and preventive actions.

This further demonstrates SANYO’s commitment to Quality Management and assurance that all regulatory practices meet the strict international standards for medical devices. This is in addition to the supplementary requirements of ISO 9001 and 14001 certifications, which are the standard for QMS and Environmental Management Systems.

Certificate Organization: NQA
Registration Number: 24438
Registration Date: April 11, 2008
Valid Date: July 11, 2011

The ISO13485 certification covers the following preservation product lines: MDF, MPR, MBR and incubation product lines: MCO, MIR, MLR, MCOK.

Definitions:

NQA- National Quality Assurance is known internationally as a premier provider of management support services, and is one of the largest quality registrars in existence, having registered over 15,000 world–class quality management systems.

About SANYO:
SANYO Electric Co., Ltd. is a multi billion dollar global leader in providing solutions for the environment, energy and for lifestyle applications based on its brand vision, ‘Think GAIA’. SANYO Commercial Solutions Company (a division of SANYO North America Corporation, a subsidiary of SANYO Electric Co., Ltd.), based in Wood Dale, IL, provides laboratory equipment for pharmaceutical, life science and biotechnology applications. Product lines include space-efficient V.I.P.® ultra-low temperature freezers, cryogenic freezers, pharmaceutical and medical refrigerators, cell culture incubators, plant growth chambers, and portable autoclaves.

For more information, please visit our web site; http://www.sanyobiomedical.com/.

For Press Inquiries:
Lauren Monitz
Marketing Communications Coordinator,
Public Relations, Branding, Web
SANYO Commercial Solutions
1300 Michael Drive
Suite A
Wood Dale, IL 60191
Phone: 630-694-8238
Email: lmonitz@sss.sanyo.com

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Contact Information:
SANYO
Lauren Monitz
Tel: 630-694-8238
Email us


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Press Release Keywords:

ISO, CMS, quality management

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