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BioMedomics, Inc.’s ISO 13485 Certification Granted Expansion

BioMedomics, Inc. is proud to announce its ISO 13485:2016 certificate has expanded in scope to include the design, development and manufacturing of COVID-19 rapid tests.  The certification is accredited by BSI Group America.

The certification of compliance with ISO 13485:2016 recognizes that the policies, practices and procedures of our company ensure consistent quality in the product and services we provide our clients. With this certification, our clients can be confident that BioMedomics, Inc. is dedicated to maintaining the highest efficiency and responsiveness in achieving our ultimate goal – guaranteed client satisfaction.

BioMedomics, Inc. is certified as meeting the requirements of ISO 13485:2016 for the following activities:

The design, development and manufacture of in-vitro diagnostic medical devices used in the detection of hemoglobin disorders and/or adaptive immune responses including laboratory and point-of-care in-vitro diagnostic medical devices.

To maintain our certification, we will perform audits to ensure compliance and to assess initiatives for continued improvement. Our clients can be confident that BioMedomics, Inc. will continue to provide the high-quality products and services they have come to expect well into the future.

We believe that our decision to expand our ISO certification to include our COVID-19 product line is a proactive one that not only anticipates the demands of our clients, but also demonstrates our commitment to providing quality services to all our clients.



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