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SAN FRANCISCO, Calif., August 4, 2016 – Fluidigm Corporation (NASDAQ: FLDM), a pioneer in single-cell analysis, today announced the company has received ISO 13485:2003 and ISO 9001:2008 certification for the design, development, manufacturing and distribution of single-cell genomics and high-throughput genomics systems. The certified San Francisco facility designs and develops instrumentation, integrated fluidic circuits (IFCs), reagents, and software, and manufactures high-performance genomic reagents and conjugated antibodies. The certified Singapore facility manufactures Fluidigm instruments and IFCs for comprehensive analysis of single cells and nucleic acids from blood, tissues, and tumor samples.
The International Organization for Standardization (ISO) is the world’s largest developer and publisher of international standards for the implementation of quality management systems. ISO 13485:2003 includes requirements for the implementation of a quality management system for the design and manufacturing of medical devices. ISO 9001:2008 specifies requirements for a quality management system to demonstrate the companies’ ability to consistently provide products that meet customer and applicable statutory and regulatory requirements.
“Our decision to invest in quality management systems, processes, and facilities was in response to our customer needs both today and in the future,” said Emi Zychlinsky, PhD, Senior Vice President of Quality and Regulatory at Fluidigm. “Simultaneous achievement of both ISO 13485 and ISO 9001 certifications through BSI reflects our commitment to provide high-quality products and customer service around the world.”
“These certifications are a significant milestone for Fluidigm, providing an important foundation to expand our business into clinical applications,” said Gajus Worthington, Chief Executive Officer of Fluidigm. “A commitment to quality is central to our mission. Providing our customers with reliable, high-performing products they can trust to answer life’s biggest questions, is our passion.”
BSI (British Standards Institution) is the business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence. Formed in 1901, BSI was the world's first National Standards Body and a founding member of the International Organization for Standardization (ISO). Over a century later it continues to facilitate business improvement across the globe by helping its clients drive performance, manage risk and grow sustainably through the adoption of international management systems standards, many of which BSI originated. Renowned for its marks of excellence including the consumer recognized BSI Kitemark™, BSI's influence spans multiple sectors including Aerospace, Automotive, Built Environment, Food, Healthcare and ICT. With 80,000 clients in 172 countries, BSI is an organization whose standards inspire excellence across the globe.
Fluidigm (NASDAQ:FLDM) develops, manufactures, and markets life science analytical and preparatory systems for growth markets such as single-cell biology and production genomics. We sell to leading academic institutions, clinical laboratories, and pharmaceutical, biotechnology, and agricultural biotechnology companies worldwide. Our systems are based on proprietary microfluidics and multiparameter mass cytometry technology, and are designed to significantly simplify experimental workflow, increase throughput, and reduce costs, while providing excellent data quality. Fluidigm products are provided for Research Use Only. Not for use in diagnostic procedures.
We use our website (www.fluidigm.com), corporate Twitter account (@fluidigm), Facebook page (https://www.facebook.com/Fluidigm), and LinkedIn page (https://www.linkedin.com/company/fluidigm-corporation) as channels of distribution of information about our products, our planned financial and other announcements, our attendance at upcoming investor and industry conferences, and other matters. Such information may be deemed material information and we may use these channels to comply with our disclosure obligations under Regulation FD. Therefore, investors should monitor our website and our social media accounts in addition to following our press releases, SEC filings, public conference calls, and webcasts.
Fluidigm and the Fluidigm logo are trademarks or registered trademarks of Fluidigm Corporation.