Complete Guide to Diagnostic Kit Manufacturing & Global Regulatory Compliance

Discover how diagnostic kits—like PCR, ELISA, and rapid tests—are developed, validated, and scaled for global distribution. This in-depth guide by Operon Strategist walks you through each phase of manufacturing, from biomarker discovery to clinical validation and ISO 13485 certification. Learn how to navigate regulatory frameworks set by FDA, EMA, and CDSCO, and get expert tips on QMS, GMP, and post-market surveillance. Trust Operon Strategist for turnkey support in diagnostic kit setup, quality assurance, and compliance worldwide.

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