Biosynex SA Secures Pivotal CE Markings Under IVDR

Biosynex SA (FR:ALBIO) has released an update.

Biosynex SA, a French health diagnostics group, has successfully acquired their first CE markings under the new IVDR regulation for a range of in vitro diagnostic products, a move that showcases the company’s expertise and provides a competitive edge in the rigorous regulatory landscape. These certifications, alongside renewed ISO 13485:2016 and IVDR quality management system certifications, position Biosynex to streamline the approval process for similar products and underscore its preparedness for future regulatory challenges. The company sees this as a validation of its team’s excellence and a testament to product quality for clients and partners.

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