Q: Where can I find Konan product IFUs (instructions for use / user manuals)?
A: IFUs can be found by visiting konanmedical.com/ifu or by submitting a support request.
Q: Does Konan provide service manuals for devices?
A: No, only certified technicians are able to open and repair Konan devices. Please submit a support request if your device requires service.
Q: How long does Konan support devices to meet regulatory requirements?
A: 5 years after sale.
Q: Where can I find more information about which Konan products are avaiable in my country?
A: Please visit our website konanmedical.com to view product info and to reach out to our sales team.
Q: Which ISO certifications does Konan Medical USA, Inc. hold?
A: Konan Medical USA, Inc. is an FDA-registered organization that holds ISO 13485:2016 certification for its quality management system, applicable to the design, manufacture, distribution and servicing of pupillographs, ophthalmic imaging devices and accessories, color vision diagnostic software, objective visual field devices and electrophysiology devices.
The certification is issued by a Medical Device Single Audit Program (MDSAP) recognized auditing organization and includes the jurisdictions of Australia, Brazil, Canada, Japan, and the United Sates.
Konan Medical USA, Inc., is also registered with the European Medical Device Regulation under MDR 2017/745. The ObjectiveFIELD Analyzer (OFA) is CE marked and approved for sale in Europe.
Konan Medical USA, Inc., is also the authorized manufacturer for Konan Medical Inc.’s CellChek product family. Konan Medical Inc. holds its own ISO 13485:2016 certification for manufacturing and MDR compliance.
For a current list of our FDA registered devices, please visit the FDA Establishment and Device Listing Database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm