At MEDIVEN, we know that when it comes to molecular testing, quality and safety are everything. That’s why we make our multiplex qPCR kits to the highest international standards. This means laboratories can trust our kits to give them accurate results, quickly and safely.
How We Guarantee Quality: Our “Pillars of Promise”
Every single MEDIVEN kit comes with a promise of quality, built on two key foundations:
- Top-Notch Manufacturing (ISO 13485 & British Standards Institution Audited): Our facility follows incredibly strict rules called ISO 13485. Think of it like a gold standard for making medical products. This ensures our PCR kits are made perfectly, from the first ingredient to the final product. Plus, our quality system is regularly checked by BSI, a world-renowned independent auditor. This extra check means you can be truly confident in the care and precision that goes into every kit.
- Safe and Proper Delivery (GDPMD Compliant): We don’t stop at making great kits; we ensure they reach you safely. Our delivery process follows GDPMD (Good Distribution Practice for Medical Devices) guidelines. This means your kits are stored and handled correctly, maintaining their integrity and performance from our facility right to your lab.
From CE to MDA: Regulatory Evolution
For years, our kits have been trusted in Europe, carrying the CE IVDD mark for quality. We’re incredibly proud of this legacy.
Now, we’re bringing that same high standard directly to Malaysia! We are delighted to announce that all MEDIVEN’s multiplex PCR kits are certified by Malaysian Medical Device Authority (MDA). This means our kits meet Malaysia’s strict performance and safety rules, making them not just recognized globally but also officially approved and trusted right here at home. This makes it easier for you to get the quality products you need, with full assurance of local compliance.
A Message to Our Customers and Partners:
Whether you’re conducting innovative research or standard diagnostics, you can rely on our established quality and regulatory transparency. Our dedication to compliance is your guarantee of excellence, not just a checkbox.
We’re committed to providing you with the best PCR solutions that you can truly rely on.
For more information on our MDA-certified, ISO 13485 manufactured, and GDPMD-distributed multiplex PCR kits, please visit our website https://mediven.com.my/.
Let’s move forward with confidence in every cycle.
