The IVDR certification allows the company to pursue market expansion within Europe's in vitro diagnostic market.

Biomerica secures IVDR (In Vitro Diagnostic Regulation) certification, ensuring compliance with stringent European Union ...

Biomerica (BMRA) announces that its food intolerance products for Crohn’s Disease and Ulcerative Colitis have achieved CE-marking under the ...

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Microbix's CEO, Cameron Groome, commented, "We are very pleased for Microbix to be recognized by candidates Premier Ford and ...

After several high-profile scandals surrounding medical devices, where irresponsible manufacturers’ malpractice in cutting corners showed how easy it was to abuse the Directive, the IVDR came ...

X AB ("2cureX") hereby publishes the interim report for the second half year of 2024. The interim report is available as an attached document as well as on the company's website ( ...

"Net sales increased during the fourth quarter by 41.5 percent to SEK 64.2 million, compared with the corresponding quarter of 2023. The growth and strong performance are a result of robust developmen ...

The company has received certification under Europe's In Vitro Diagnostic Regulation for a number of tests recently.

Ikeda's expertise includes FDA and EU submissions for the IVD industry, such as 510(k), premarket approval (PMA), PMA supplements, annual reports, and Class D IVDR dossiers.