Quality & Compliance
Certified. Registered.
Trusted.
Disposafe holds the highest level of regulatory approval across six key global markets, independently audited and continuously maintained.
Quality & Compliance
Disposafe holds the highest level of regulatory approval across six key global markets, independently audited and continuously maintained.
Our Approvals
Every certification we hold is actively maintained, not obtained once and filed away.
From the EU to Australia, from the US to Japan, Disposafe maintains active regulatory approval in every major medical device market. Our compliance team manages ongoing surveillance audits, post-market obligations, and regulatory submissions across all jurisdictions.
Quality Assurance
Our certifications are the result of disciplined quality management, not achieved by paperwork alone, but by the rigour embedded in our manufacturing operations.
Systematic, documented quality control at every stage, from incoming raw materials through in-process inspection to final device release.
Annual audits by TÜV SÜD and ongoing FDA surveillance maintain our certification status and keep our QMS current with evolving global standards.
Every employee, from the cleanroom floor to senior management, is trained and accountable to our quality standards.
Manufacturing Infrastructure
ISO Class 7 and Class 8 controlled environment, one of India's largest dedicated medical-device cleanroom facilities.
Full in-house tooling capability enables precise, consistent device geometry, critical for regulatory conformance across 70+ SKUs.
Validated ethylene oxide sterilization on-site ensures sterility assurance levels (SAL 10⁻⁶) for every packaged product.
Our regulatory team can provide certificates, registrations, and technical files for your market access requirements.