Konan Medical USA Achieves ISO 13485 Certification

Share Article

International certification milestone reached in preparation for entry of RAPDx product into EU, Canada and other countries.

Ophthalmic device products include CellChek XL specular microscope and the RAPDx pupillograph

novel diagnostic products for the eye care professions

Konan Medical USA is an ISO 13485 certified company and a leader in the supply of novel diagnostic devices for Ophthalmology, Optometry, and Eye Banking.

Konan Medical USA, the US market leader in specular microscopy, reported that its Quality Management System has been certified to the requirements of both ISO 13485:2003 and the Canadian Medical Device Conformity Assessment System (CMDCAS) by Intertek, a notified body based in the United Kingdom.

An internationally recognized standard, ISO 13485 specifies requirements for a quality management system governing design, manufacture, and support of medical devices, and is a cornerstone for medical device companies to gain entry into a significant number of the world’s developed markets. Certification of Konan’s quality system is a critical step towards CE Marking its newly announced RAPDx pupillography product in European, Canadian and other jurisdictions that recognize the CE Mark.

“Konan has significant time and resources invested in developing and implementing our Quality Management System and we are pleased to have achieved this milestone in less than one year,” said Charles Wm. Stewart, OD, CEO of Konan Medical USA. “Konan’s quality system certification is a strong testament to the team’s efforts to deliver high quality diagnostic products and services for Ophthalmology, Optometry and the Eye Bank industry,” added Dale Sadlik, COO. “This is significant step in the growth of Konan”.

About Konan Medical USA, Inc. (“Konan”). Konan is an ISO certified medical device company based in Irvine, California with a focus on novel diagnostics for the eye care market segment. Konan Medical USA develops, sells, and services products both from its parent company (Konan Inc. Hyogo, Japan) and those developed in the USA. The flagship specular microscope products (CellChek XL and CellChek EB-10) are widely regarded as the gold standard and are used by both by industry to support FDA clinical trial safety endpoints and in routine clinical practice for analysis of the eye’s corneal endothelium. Konan’s newest product “RAPDx” is a high definition pupillograph to measure a key defect in pupil function.

For more information, visit http://www.Konan-USA.com or http://www.RAPDx.com or contact: Konan Medical USA, Inc., Dale Sadlik +1 (949) 521-7730 X 7748 or dsadlik(at)konan-usa(dot)com

###

Share article on socal media or email:

View article via:

Pdf Print

Contact Author

Dale Sadlik
Konan Medical USA, Inc.
+1 (949) 521-7730 7748
Email >
Visit website