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Nexsen Advances Regulatory Readiness with Stage 1 ISO 13485 Audit Completion

8:36am on Tuesday 7th of April, 2026 AEST 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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