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Mirus Bio Achieves ISO 13485:2016 Certification: A Milestone in Quality Management

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Mirus Bio, a renowned life sciences company, has recently marked a significant milestone by achieving the ISO 13485:2016 certification.

This accomplishment underscores the company’s commitment to maintaining the highest quality standards in its operations, particularly in the development of innovative solutions for nucleic acid delivery, which are crucial in cell and gene therapy production, biopharmaceutical manufacturing, and research applications.

A Testament to Quality and Excellence

The ISO 13485:2016 certification is not just a badge of honor; it’s a testament to Mirus Bio’s dedication to quality management.

Jena Lange, the Director of Operations at Mirus Bio, expressed pride in the team’s efforts to successfully complete the rigorous certification process.

This achievement verifies the robustness of their customer-centric Quality Management System (QMS), reflecting their commitment to meeting the needs of their customers in cell and gene therapy as a trusted partner.

What Does ISO 13485:2016 Certification Mean?

The ISO 13485:2016 standard, developed by the International Organization for Standardization (ISO), sets a framework for a comprehensive management system for the design and manufacture of medical devices.

For Mirus Bio, receiving this certification confirms that their management of the organization aligns with the high standards established by the ISO 13484:2016 Medical Device Standard.

It emphasizes efficient processes to deliver effective products while complying with regulatory and statutory requirements.

A Collective Achievement

Dale Gordon, CEO of Mirus Bio, highlighted the certification as a collective achievement of all employees, achieved through a process led by their QA team.

This recognition is a reflection of the company’s intense focus on achieving the highest standards of quality across the organization.

About Mirus Bio

Mirus Bio has been a pioneer in nucleic acid delivery, enabling scientific research and innovation for over two decades.

They are a leading provider of transfection products for the biopharmaceutical and research industries, offering best-in-class reagents for gene therapy, recombinant protein, and stem cell applications. In 2021, the company introduced VirusGEN® GMP Transfection Reagent and Enhancers, further expanding their support in the commercial biopharmaceutical and cell and gene therapy markets.

This certification marks a new chapter for Mirus Bio, reinforcing their position as a leader in the life sciences sector and their unwavering commitment to quality and excellence.

*** All content on is for informational purposes only. All medical questions and concerns should always be consulted with your licensed healthcare provider.

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