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Quality Management
Bionostix operates under a certified quality management system to ensure controlled manufacturing, product consistency, and regulatory compliance for in-vitro diagnostic reagents.
Our quality framework governs all stages of production, from material handling and formulation to batch documentation and release, supporting reliable supply for regulated diagnostic markets.
Quality Management System
Bionostix maintains an ISO 13485–certified quality management system for the manufacture of in-vitro diagnostic products. All production activities are performed in accordance with documented procedures covering manufacturing controls, quality control, batch records, and product release.
Quality responsibilities are integrated across manufacturing and quality functions to ensure traceability, reproducibility, and consistent product performance.
Regulatory Context
Bionostix acts as an approved manufacturing site for selected in-vitro diagnostic products that are CE marked under the In Vitro Diagnostic Directive (IVDD) by their respective legal manufacturers. Manufacturing activities are performed in alignment with the applicable regulatory documentation and quality requirements defined by the CE-marking legal entity.
This role enables Bionostix to support regulated market supply while maintaining clear separation between manufacturing responsibilities and legal manufacturer obligations.
Traceability & Product Control
All manufactured products are subject to defined controls for batch traceability, documentation, and release. Materials, formulations, and finished goods are tracked throughout the production process in accordance with ISO 13485 requirements.
This structured approach supports consistent quality, audit readiness, and long-term collaboration with legal manufacturers and distribution partners.
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