by Syrma Johari MedTech | Dec 10, 2025 | Blog
In recent years, the regulatory landscape for aesthetic device manufacturers has evolved significantly. Devices previously categorized as wellness products, including many energy-based platforms, are now subject to medical-grade scrutiny worldwide. Consumer demand...
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...
