Spear Bio receives ISO 13485:2016 certification

Ultrasensitive immunoassays developer Spear Bio has announced that it has received ISO certification for operating a “Quality Management System which complies with the requirements of ISO 13485:2016.”

To be certified, organizations must demonstrate that their Quality Management Systems are able to provide medical devices and related services that consistently meet customer and regulatory requirements.

Spear Bio’s Certificate of ISO Registration, issued by BSI Group, an independent certifying body, found the company’s Quality Management System in compliance with ISO 13485 requirements for the “design, development and manufacturing of in vitro diagnostic reagents and test kits for the screening of infectious diseases.”

“Everyone at Spear Bio can be proud of this ISO certification” said Spear Bio CEO, Jerome Clavel. “It’s a recognition of our efforts to maintain the highest quality products and services for our customers.”

According to the International Organization for Standardization (ISO), organizations can reap many benefits from implementing the ISO 13485 standard without undergoing the certification process. However, third-party certification can demonstrate to regulators that companies have met all the ISO 13485 requirements.

Spear Bio, founded in 2021 by scientists from the Wyss Institute for Biologically Inspired Engineering at Harvard University, is headquartered in Woburn, MA. The company is focused on developing robust, ultrasensitive immunoassays for tiny sample volumes.

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