FUJIFILM Irvine Scientific receives CE mark approval for multiple ART media
Innovative ART products now available in Europe.
FUJIFILM Irvine Scientific has announced the receipt of CE Mark approval for key ART products. CE Marking is a distinction that the products conform to standards set by the European Union health and safety legislation.
The products that received CE Marking include:
Fujifilm Irvine Scientific is devoted to meeting or exceeding regulatory standards worldwide and was one of the first ART manufacturing companies in the US to receive ISO 13485 Quality System certification, the rigorous international quality assurance standard designed specifically for medical devices. Each product is manufactured in accordance with the Guidelines for Manufacture of Medical Device and In Vitro Diagnostic Products and the Good Manufacturing Practices (GMPs) for Medical Devices.
“Fujofilm Irvine Scientific leads the way in production of high-quality ART solutions that consistently meet worldwide regulatory requirements,” said Marc Brignola, Senior Director Sales and Marketing, Assisted Reproductive Technologies. “We are pleased to now offer these innovative solutions to all of our European customers.”
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