QA & Regulatory

QA & Regulatory

Quality Assurance and Regulatory

In the dynamic landscape of medical device manufacturing, ensuring the highest standards of quality and compliance with regulatory requirements is paramount. Our commitment to excellence is reflected in our robust Quality Assurance (QA) and Regulatory Affairs (RA) processes.

Our Quality system follows the ISO 13485, 21 CFR part 820 and Fifth Schedule of Medical Device Rule-2017.Navigating the complex landscape of regulatory requirements is fundamental commitment to compliance. This encompasses global regulations USFDACECDSCO and EUDAMED

QA & Regulatory

ISO 13485 : 2016

QA & Regulatory

CE 2803

QA & Regulatory

USFDA

QA & Regulatory

CDSCO

QA & Regulatory

EUDAMED

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