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eDHR

Achieve the highest quality outcomes with the complete digitalization of production and quality documentation with fully searchable and self-auditing electronic DHRs/BRs. Material traceability and genealogy is provided at the individual batch, lot, or unit level, meeting full compliance with the latest EU Medical Device Regulation (MDR) requirements and Unique Device Identifier (UDI) tracking. The comprehensive system exceeds regulatory requirements such as FDA 21 CFR Parts 11 and 820. Reporting for audits is easy to assemble and in the event of regulatory action or recall, the system enables rapid and precise identification of finished goods to minimize negative impact.