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Nexsen Advances Regulatory Readiness with Stage 1 ISO 13485 Audit Completion
8:36am on Tuesday 7th of April, 2026 AEST
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Healthcare
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Nexsen Advances Regulatory Readiness with Stage 1 ISO 13485 Audit Completion
8:36am on Tuesday 7th of April, 2026 AEST
Key Points
Stage 1 ISO 13485 audit successfully completed by BSI
QMS structured to support clinical validation, regulatory submissions, and manufacturing
Progressing toward full ISO 13485 certification and MDSAP alignment
QMS underpins Nexsen’s global regulatory and commercial rollout strategy
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NEXSEN (ASX:NXN)
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