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Volpi USA ISO 13485 Certification Announcement


AUBURN, USA, Oct. 28, 2016


The Volpi Group today announced that its U.S. branch has earned ISO 13485 certification. The certification demonstrates that Volpi USA has met the highest international standard for quality management systems used in the design and manufacture of medical devices. 

Volpi USA’s ISO 13485 certification complements the same accreditation achieved by its Swiss sister company. The dual certification gives Volpi the flexibility to develop and produce medical devices at both sites and to collaborate between them without regulatory restriction. 

Volpi USA’s certification is an important strategic milestone for the company as it continues its focus on the in vitro diagnostics, medical technology and life science research markets. Volpi now meets the highest quality standards[1] for these industries and can act as a trusted partner with companies in the highly-complex regulatory environments governed by the U.S. Food and Drug Administration (FDA) and the Medical Devices Directive. For example, ISO 13485 is similar to the U.S. medical device quality system regulations detailed in FDA 21 CFR part 820. The company continues to serve customers whose projects must meet less stringent regulatory requirements.

“The ISO 13485 certification of Volpi USA is the result of the tremendous commitment of our company to achieving the highest international standards of quality with our U.S. systems, facilities and employees,” said Terrence Howell, Volpi’s director of global quality. “Volpi now has a uniform quality benchmark across all of our operations. Volpi’s certification at both sites gives us added credibility and clout as we increase our focus on the medical device industry and partnering with companies that must manufacture their products under the ISO 13485 standard.”

[1]Volpi also meets the standards of ISO 14971, 62366, 62304 and 9001.

Press contact:
Dr. Harald Kraushaar
Executive Vice President, Head of Sales & Marketing