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Modular Medical, Inc. (Nasdaq:MODD) ("Modular Medical" or the "Company"), a leader in innovative insulin delivery, today announced that it is continuing to progress toward CE Mark certification under the European Union Medical Device Regulation ("EU MDR 2017/745"). As part of this process, the Company is pleased to announce the successful completion of its Stage 1 ISO 13485:2016 audit, conducted by BSI, its Notified Body and Registrar.
The audit evaluated Modular Medical's quality management system ("QMS") for compliance with ISO 13485:2016 and alignment with EU MDR 2017/745 requirements, to confirm that the Company's QMS is robust and well-documented, with no major nonconformances identified.
Posted In: MODD
