Quality and Regulatory
Ensuring Compliance, Safety & Quality
We ensure that our design and manufacturing services comply with 21 CFR Part 820, helping medical device, life sciences, and biotech OEMs meet regulatory requirements.
Our ISO 13485-certified quality management system (QMS) integrates:
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Design for Compliance (DFC)
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Process validation (IQ/OQ/PQ)
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Statistical Process Control (SPC)
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Electronic batch records & real-time deviation tracking
As a 21 CFR Part 820-compliant manufacturer, we meet global standards for safety, risk management, reliability, and regulatory approval through validated, repeatable processes.
We maintain compliance with ISO 13485, ISO 9001, ISO 14001, ISO 45001, IATF 16949, and CTPAT.
Our commitment to quality ensures reliability, regulatory compliance, and end-to-end traceability throughout the entire product lifecycle.
