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Nexsen clears quality hurdle as StrepSure advances towards FDA review
9:20am on Monday 2nd of November, 2026 AEDT
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Healthcare
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Nexsen clears quality hurdle as StrepSure advances towards FDA review
9:20am on Monday 2nd of November, 2026 AEDT
Key Points
ISO 13485:2016 certification secured for StrepSure’s quality management system
Certification covers design, development and manufacture
QMS meets MDSAP requirements recognised by the FDA and TGA
Hong Kong remains the planned Asia-Pacific commercial entry point
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