Innokas Medical was chosen to co-operate with Optomed by offering quality consulting services for helping the company to streamline their processes according to QMS to ensure the regulatory requirements are met through the product whole life cycle. In practice, Innokas has supported Optomed in their QMS updates with internal audits and providing up-to-date information about regulatory requirements, as well as offered quality training related to FDA requirements.

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“Innokas QA/RA team’s knowhow and long experience in medical device design projects, production and regulatory requirements is comprehensive and they are able to partner with their customers by giving clear and concrete advices about quality and regulatory related issues. We are very satisfied with the co-operation with Innokas, and we definitely want to continue our cooperation with Innokas in the future, also”, Jyri Leskelä, Quality Manager at Optomed says.

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Optomed Oy is a Finnish medical technology company that specializes in retinal imaging devices and solutions. Optomed was established in 2005. The company’s product portfolio consists of unique digital imaging instruments that provide retinal and eye anterior imaging with one portable device. Optomed’s key product is Smartscope® PRO, a modular hand-held retinal camera for screening and diagnosis of various eye diseases, such as diabetic retinopathy, glaucoma and AMD. It is the smallest product on the market with high image quality, which fulfills international ISO 10940 fundus camera standard requirements.