No, TOYOTEC, which operates Optical Design Engineering Navigator, is not currently ISO13485 certified.
However, we have been dealing directly with medical device manufacturers for many years and have experience in the mass production and supply of optical components used in medical testing, such as those used in ophthalmology and blood cell analyzers.
In addition, we produce small lot products in a clean environment, with monthly production of around 100 units.
At moment there is no requirement to obtain ISO 13485 for suppliers of manufactured parts used in finished products such as our company, but
we are actively seeking the business opportunities in the medical field, which is expected to grow in the future, as a supplier of optical components in any form.
Please feel free to contact us if you have any questions about product development and manufacturing. For more information, please feel free to contact us.