At Vivan Meditech, every Medical Disposable Item is manufactured under stringent global protocols. Our certifications are not just documents—they are a testament to our unwavering commitment to Quality Control and regulatory compliance, ensuring reliable Medical Supplies for your institution.
This is the Gold Standard for medical device manufacturers worldwide. Our ISO 13485 certification confirms that Vivan Meditech's entire process—from design and production to service—meets the comprehensive regulatory requirements for patient safety and efficacy.
The CE Mark signifies that our products meet the essential health, safety, and environmental protection standards required for sale within the European Economic Area. This provides global reassurance that our CE Certified Syringes and devices are safe for intended use.
Applied to: All exported Medical Disposable Items and devices listed under the European Directives.
Product Safety and compliance for international markets.
Adherence to WHO-GMP demonstrates our commitment to producing products of consistent quality. It assures users that our sterile medical consumables are manufactured and controlled according to the highest quality standards globally.
Our commitment to patient safety is executed through a multi-stage Quality Control Process meticulously aligned with ISO 13485:2015 standards. From raw material sourcing to final sterilization, Vivan Meditech implements stringent checks to ensure that every Medical Disposable Item delivers flawless performance and reliability.
All incoming components and materials are subjected to comprehensive testing to verify biocompatibility, purity, and adherence to our specific quality standards before entering the manufacturing line.
Continuous Quality Control monitoring at critical assembly points (e.g., bonding, printing, component fit) to detect and correct deviations instantly. This ensures high-precision manufacturing.
Rigorous sampling and testing of the finished product, focusing on sterility, leakage tests, functionality (e.g., plunger smoothness for syringes), and packaging integrity.
Every batch is assigned a unique traceability code. Products are released only after final documentation approval, ensuring compliance and the ability to track every Surgical Consumable to its source.
Reach out to us for detailed documentation and certification copies.