Why ISO 13485 Certification Matters for Class A & B Medical Devices | CDSCO Compliance Guide

ISO 13485 certification is a critical quality benchmark for medical device manufacturers, including those producing low-risk Class A and B devices. While the CDSCO may not mandate ISO 13485 for every case, aligning with this international standard ensures product consistency, regulatory compliance, and readiness for audits. It supports smoother approval processes—such as CDSCO Form MD-7—and signals to regulatory bodies and customers that your manufacturing practices are built on globally accepted quality systems.

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