Covaris Awarded ISO 13485 Quality System Certification
WOBURN, MA, February 13th, 2025 - Covaris LLC, a PerkinElmer subsidiary and a global leader in sample preparation technologies for life sciences research and molecular diagnostics applications, today announced that it has successfully been awarded ISO 13485 Quality System Certification. This certification demonstrates Covaris' commitment to meeting the highest international standards for medical device quality management systems and ensuring the high quality of life science research data for research and innovation.
ISO 13485 is an internationally recognized standard that specifies requirements for a quality management system in the medical device industry. It ensures that organizations can consistently meet customer and regulatory requirements applicable to medical devices and related services.
"Receiving the ISO 13485 certification is a testament to our teams’ dedication to quality and meeting the highest international regulatory standards," said Annemarie Watson, Covaris’ CEO. "Covaris sample prep solutions are recommended in many well-known cancer testing protocols, and this achievement ", she concluded.
The broad scope of Covaris' certification includes the design, development, production, and distribution of its advanced sample preparation instruments and consumables. This certification will further strengthen Covaris’ ability to serve customers in regulated markets that require ISO 13485 compliance.
Founded in 1999 and headquartered in Woburn, Massachusetts, Covaris has established itself as an industry leader in developing end-to-end solutions for high-throughput genomic and proteomic analysis. The company's innovative technologies, including its Focused-ultrasonicators and cryopulverizing systems, have been widely adopted in research, laboratory, and pharmaceutical settings.
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