Spear Bio achieved ISO 13485:2016 Certification


The Comprehensive Quality Management System for the Production of Medical Devices at Spear Bio has been Certified by BSI as Meeting a Third-Party Verified International Standard.

Developer of ultrasensitive immunoassays Spear Bio has declared that company has achieved ISO accreditation for running a “Quality Management System which complies with the requirements of ISO 13485: 2016.”

For an organisation to be certified, it must be able to show that its quality management system can consistently deliver medical devices and related services that satisfy both customer and legal criteria.

According to the independent certifying body BSI Group, which issued Spear Bio’s Certificate of ISO Registration, the company’s Quality Management System complies 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.”

The International Organisation for Standardisation (ISO) asserts that businesses can get several advantages by following the ISO 13485 standard without going through the certification procedure. Nevertheless, third-party certification can show authorities that businesses have complied with all ISO 13485 regulations.

SOURCE:- https://www.prnewswire.com/news-releases/spear-bio-receives-iso-134852016-certification-301903927.html


Please enter your comment!
Please enter your name here