Nexsen Limited (ASX:NXN) has completed its Stage 1 ISO 13485 audit, confirming its Quality Management System (QMS) supports clinical validation and regulatory submissions for its diagnostic products, including StrepSure®. The company is progressing toward full certification and alignment with MDSAP requirements to facilitate global market access.
- 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
- Supports market expansion in US, Asia-Pacific, and Europe
Stage 1 ISO 13485 Audit Milestone
Nexsen Limited (ASX:NXN) has announced the successful completion of its Stage 1 ISO 13485 audit, conducted by BSI, a globally recognised certification body. This audit assessed the company’s Quality Management System (QMS), which is fundamental to the development, clinical validation, regulatory submissions, and future commercial manufacturing of its diagnostic products, including its lead test, StrepSure®.
Managing Director Mark Muzzin highlighted the importance of this milestone, stating that the audit confirms the QMS is appropriately structured to support Nexsen’s clinical and regulatory programs across multiple regions. The company is now progressing toward the Stage 2 certification audit, aiming for full ISO 13485 certification and alignment with the Medical Device Single Audit Program (MDSAP) requirements.
Implications for Regulatory and Commercial Expansion
A certified QMS is a foundational requirement for regulatory approvals and commercial supply in global markets. Nexsen’s progress supports its ability to advance regulatory and commercial activities in key jurisdictions, including the United States and other MDSAP-participating countries, Australia, Asia-Pacific, and Europe.
Alignment with MDSAP is expected to streamline regulatory inspections by enabling a single audit framework across multiple jurisdictions, potentially reducing regulatory complexity and facilitating more efficient market access. ISO 13485 certification also underpins clinical validation and early commercial deployment in Australia and Asia-Pacific, while forming a critical requirement for regulatory approval and market entry in Europe.
Context Within Nexsen’s Broader Strategy
This development follows Nexsen’s recent announcements regarding its clinical validation and regulatory submission plans for StrepSure®, including targeted FDA submissions and early commercialisation efforts in Asia-Pacific markets. The company’s subsidiary recently secured a HK$6 million grant to support clinical validation and manufacturing scale-up in Hong Kong, establishing a manufacturing and distribution hub for the region.
While the Stage 1 audit completion is a significant step, the timing and outcome of the Stage 2 certification audit remain to be seen. Forward-looking statements in the announcement caution that various risks and uncertainties could affect the company’s regulatory and commercial progress.
Bottom Line?
Nexsen’s QMS audit milestone lays important groundwork for regulatory approvals and commercial rollout, though full certification and market entry timelines remain subject to regulatory processes and market conditions.
Questions in the middle?
- When will Nexsen complete its Stage 2 ISO 13485 certification audit and achieve full certification?
- How will alignment with MDSAP impact Nexsen’s regulatory submission timelines across different jurisdictions?
- What are the potential challenges Nexsen may face in scaling manufacturing and commercial supply following certification?