Omega Bio-tek Announces Earning ISO 13485:2016 Certification

Omega Bio-tek Earns ISO 13485 Medical Devices Quality Management Systems Certification From NSF International Strategic Registrations (NSF-ISR)


Omega Bio-tek, a leading nucleic acid purification kit manufacturer, announced today that the company received ISO 13485:2016 certification for Medical Devices- Quality Management Systems. This certification is an internationally recognized standard for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more life cycle stages, including design and development, production, storage and distribution, installation, or servicing of a medical device, or provision of associated activities

“For over 7 years, Omega Bio-tek has been ISO 9001 certified and by obtaining the ISO 13485 certification, it demonstrates our continued commitment to providing high-quality products, meeting customer expectations, regulatory compliance, and risk-based decision making,” said Travis Butts, Vice President for Omega Bio-tek. “This certification enables Omega Bio-tek to continue to develop nucleic acid purification products with the highest standards for reliability, safety, and product performance.”

Omega Bio-tek has achieved ISO 13485 certification from NSF-ISR, an NSF International company that is accredited by the ANSI National Accreditation Board (ANAB). The ANAB provides services in more than 75 countries and is the largest accreditation board in North America.

About Omega Bio-tek, Inc.

Omega Bio-tek, founded in 1998, is an ISO 9001:2015 and ISO 13485:2016 certified, industry-leading manufacturer of DNA/RNA purification kits for clinical, biotechnology, and genomics research. With a diversified product portfolio for low-throughout to high-throughput purification, Omega Bio-tek kits purify high-quality nucleic acids from a wide variety of samples. Omega Bio-tek’s products and services are used in thousands of universities and research institutes and over 100 different countries worldwide.

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NSF International Strategic Registrations (NSF-ISR) is a leading global certification body known for its technical expertise and customer satisfaction. NSF-ISR offers comprehensive management systems certifications to internationally accepted standards for quality assurance and environmental protection for the automotive, aerospace, chemical, energy, medical, and manufacturing industries (e.g. ISO 9001, ISO/IEC27001, ISO 45001, AS9100, IATF 16949, etc.).
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