Mediomics, LLC certified to ISO 9001: 2015 Standards

Mediomics, LLC certified to ISO 9001: 2015 Standards

Mediomics, LLC is pleased to announce certification of their Quality Management System to the ISO 9001:2015 standard, effective September 1st 2018. Mediomics had previously earned certification under the ISO 9001:2008 standard on September 1st 2015 and was audited annually to ensure conformance to the standard. 

Mediomics’ primary goal is to meet the needs of their customers within the research field by producing a range of high quality assay kits used to detect various biological and therapeutic macromolecules. The ISO 9001:2015 standard helps them stay true to this goal. This is done by ensuring that their Quality Management System details the customers’ needs and requirements and critically evaluates any relevant risks or opportunities that may affect those needs. Certification to the ISO 9001:2015 standard is a reflection of Mediomics’ dedication to continual improvement, strong customer service, and the manufacturing of quality products.

Mediomics looks forward to continuing to serve the needs of the larger scientific community.

Mediomics, LLC Earns ISO 9001 Certification



St. Louis, Missouri – October 30, 2015 – Mediomics, LLC, a St. Louis based innovator and manufacturer of assay kits and biosensors for physicians, hospitals, laboratories and other organizations in the medical field, recently received ISO 9001:2008 certification from the International Organization for Standardization (ISO).

To receive ISO 9001:2008 certification, Mediomics, LLC had to meet a set of comprehensive quality system requirements and pass an independent third party audit.

“This is like a doctor passing the medical boards or a lawyer passing the bar exam,” said, Dr. Yie-Hwa Chang company Founder and President.  “And, we are very proud of the way our staff performed during the preparation and audit process,” he continued. “The company has been in business since 2001 and we see this achievement as a major step in maintaining our business position and product quality in support of our customers.” said Dr. Chang

“With the new ISO certification, we expect to continue our growth and enter new markets where such a registration represents part of the criteria for consideration,” Dr. Chang added.

ISO 9001:2008 certification helps both product and service oriented organizations achieve standards of quality that are recognized and respected throughout the world.

Mediomics LLC’s patented technology provides the quick detection of biomolecules, which will revolutionize the ability of medical facilities and physician’s offices to do onsite testing for their patients faster and more cost effectively.

These quick and simple test kits are used to quantify many biologically and therapeutically important macromolecules, including DNA, biomarkers, hormones, antibodies, intracellular signaling molecules, protein-protein complexes, bacteria, fungi and viruses.

In simplest terms, Mediomics’ technologies can do a wide variety of common medical tests faster and cheaper than conventional testing methods.

To date, Mediomics, LLC has received $5.6 million in highly competitive SBIR/STTR Phase I/II grants from the National Science Foundation, the National Institutes of Health and the Department of Defense. The company is located in a 4,500 SQ’ facility equipped with state-of-the-art research and production equipment.

During the certification process, Missouri Enterprise ISO experts provided Mediomics, LLC, with training, documentation preparation and implementation assistance, auditing support and on-site support.


For More Information, Contact:

Harold Zinn, Vice President

Corporate Communications

314-434-6300 ext 1301

314-971-1837 (mobile)

[email protected]