Vivantis Technologies Sdn Bhd

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Home Latest news ISO 13485:2016 Quality Management System – Now Certified

ISO 13485:2016 Quality Management System – Now Certified

Vivantis Technologies Sdn Bhd (Vivantis) has been certified that the company’s quality management system complies with the requirements of ISO 13485:2016. It signifies that Vivantis has established a comprehensive quality management system for design, development and manufacture of IVD products (nucleic acid extraction kits and biomolecular based in vitro diagnostics medical devices).

“This is one of a great milestone for the company in line with company’s mission to continuously improve, upgrade and maintain quality management system to manufacture high quality products to customers around the world,” said CEO of Vivantis, Mr. EL Law.

“This accomplishment represents high level of commitment of all individuals within the organization who believe that this achievement of ISO certification resonates with Vivantis’s commitment to the highest level of quality management and to accomplish operational and production excellence.”

Products that comply with ISO13485:2016 Quality Management System listed as below:

  1. GF-1 Viral Nucleic Acid Extraction Kit
  2. ViPrimePLUS 2019-nCoV RT-qPCR Kit
  3. ViPrimePLUS Lyophilized One Step qRT-PCR Master Mix

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Vivantis Technologies Sdn Bhd

Revongen Corporation Center,

Level 17, Top Glove Tower,

No. 16, Persiaran Setia Dagang,

Setia Alam, Seksyen U13,

40170 Shah Alam,

Selangor Darul Ehsan,


Tel: +603-3359 1166

Fax: +603-3358 0303




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