by Syrma Johari MedTech | Dec 2, 2025 | Blog
In vitro diagnostic (IVD) tests are essential medical tools to diagnose and monitor a wide range of diseases. Among the various IVD techniques, immunoassays are one of the most widely adopted bioanalytical platforms. They detect and quantify biomarkers by utilizing...
by Syrma Johari MedTech | Nov 20, 2025 | Blog
In high-risk medical device manufacturing, quality serves as a foundational operating principle that defines commercial success and regulatory readiness. Thus, treating Quality Assurance and Regulatory Affairs (QARA) as a downstream function can be a costly mistake...
by Syrma Johari MedTech | Nov 14, 2025 | Blog
Tariff engineering is the legitimate practice of designing a product, its components, or its classification to ensure that, upon import, it qualifies for a lower tariff rate. This is not tariff evasion—it is a deliberate, commercially sound, and technically defensible...
by Syrma Johari MedTech | Nov 14, 2025 | Blog
Medical devices are built on globally distributed value chains: for example, sensors from Japan, plastics from Mexico, electronics from Asia, final assembly in the U.S. or EU, and post-market service worldwide. For much of the last three decades, this ecosystem scaled...
by Syrma Johari MedTech | Nov 5, 2025 | Blog
Post-COVID, in vitro diagnostic (IVD) has transitioned from episodic use to being integral across precision medicine, preventive care, and consumer health. The pandemic drove unprecedented demand, with the global IVD market surging by 45.4% in value from 2019 to 2020....
by Syrma Johari MedTech | Oct 23, 2025 | Blog
In today’s high-stakes MedTech landscape, your supplier network directly reflects your product integrity, regulatory posture, and time-to-market reliability. For manufacturers of Class II and III devices, supplier non-conformance can trigger far more than a CAPA. It...
