Optomed rely on Innokas’ strong expertise in quality and regulatory affairs

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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.

Innokas Medical has co-operated 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.

“The cooperation with Innokas helps us to ensure that all the quality and regulatory requirements that the authorities have appointed to this sector, are taken into account in Optomed’s internal processes. Innokas’ QA/RA team has, for example, audited our internal processes and practices, and identified some areas with clear and concrete advices on how to develop our processes. In addition, Innokas offered us very knowledgeable FDA-training, and as an outcome our personnel’s understanding of FDA requirements has grown and become more concrete. The valuable knowhow we were able to gain in-house through Innokas FDA-training created added value for our company, this is just one reason why we will definitely continue our cooperation related to FDA-training with Innokas QA/RA team”, Jyri Leskelä, Quality Manager at Optomed says.

Leskelä sees Innokas as an excellent partner for a healthcare technology company especially because of its very strong expertise in quality and regulatory affairs. He tells that Optomed has been very satisfied with the cooperation with Innokas QA/RA team, and he sees that the co-operation with Innokas will continue also in the future.

“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”, Leskelä concludes.

Picture of Elina Ihme
Written by Elina Ihme
Head of Marketing and Communications
Quality & Regulatory Affairs, FDA, ISO 13485, Customer Success Story