Mirus Bio receives ISO 13485:2016 certification, underscoring the quality of processes used to support GMP product portfolio. Read more

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Mirus Bio Receives ISO 13485:2016 Certification

Completion of this comprehensive certification process underscores the quality of the processes used to support the company’s GMP product portfolio

MADISON, Wis., January 31, 2024 — Mirus Bio, a life sciences company developing innovative solutions for nucleic acid delivery to support cell and gene therapy production, biopharmaceutical manufacturing, and research applications, today announced that its quality management system (QMS) has achieved ISO 13485:2016 certification.

“I’m incredibly proud of our team for successfully completing the rigorous process to receive ISO 13485 certification for our GMP product portfolio,” said Jena Lange, Director of Operations at Mirus Bio.  “This milestone verifies that we have developed and implemented a robust customer centric QMS which reflects our commitment to meeting the needs of cell and gene therapy customers as a trusted partner.”

The ISO 13485:2016 standard was developed by the International Organization for Standardization (ISO). Receipt of this certification confirms that Mirus Bio demonstrates the management of its organization meets the framework and principles established by the ISO 13484:2016 Medical Device Standard. This is achieved by efficient processes to deliver effective products while complying with applicable regulatory and statutory requirements.

“Across our organization, we are intensely focused on achieving the highest standards of quality,” said Dale Gordon, CEO of Mirus Bio.  “Earning this internationally recognized certification, through a rigorous process led by our QA team, is a collective achievement of all our employees.”

Mirus Bio Receives ISO 13485:2016 Certification

Completion of this comprehensive certification process underscores the quality of the processes used to support the company’s GMP product portfolio

View the certificate
MIRUS BIO ISO:13486

Contact Us

Atsuko Trieloff
maildesk@mirusbio.com
608-229-1426