Latest News for: iso 13485

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Median Technologies Achieves ISO 13485:2016 Certification for eyonis® Medical Device Quality Management System

Business Wire 19 Mar 2026
... it has achieved the globally recognized ISO 13485.2016 certification for its Quality Manage .
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BS EN ISO 13485:2016 Medical Device Single Audit Programme (MDSAP) Training Course (June 25th - ...

Nasdaq Globe Newswire 25 Feb 2026
It enhances compliance, reduces regulatory barriers, and improves risk management ... .
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Zero Candida Scales Production to 250 ISO 13485 Clinical-Grade Prototypes of ZC-001 Therapeutic Device USA ...

Canada Newswire 17 Feb 2026
... solutions for women's health, today announced that it is scaling manufacturing to 250 clinical-grade prototypes of its ZC-001 therapeutic device under ISO 13485-certified quality standards.
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PPC Flex Achieves ISO 13485 Certification, Expanding Capabilities for Pharmaceutical and Medical Markets

ACCESSWIRE 05 Feb 2026
The ISO 13485 certification enhances the company's reputation as a reliable partner for customers who demand the highest levels of regulatory compliance and process control ... "The ISO 13485 certification embodies some of our core PPC Flex values.
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Co-Diagnostics JV, CoSara, Receives ISO 13485 Certification in Preparation for Manufacturing Upcoming PCR Platform

HJ News 04 Feb 2026
Company and CoSara believe that ISO certification is a critical component of the regulatory requirements for clearance of new platform ....
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28/01/2026 - PHARMANUTRA S.P.A. OBTAINS ISO 13485 CERTIFICATION (Pharmanutra SpA)

Public Technologies 28 Jan 2026
OBTAINS ISO 13485 CERTIFICATION ... The ISO 13485 ... Food and Drug Administration (FDA) will harmonize its requirements for medical devices (Quality Management System Regulation - QMSR) with ISO 13485.2016.
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