Medical device classes are risk-based categories that shape evidence requirements, submission route, review depth, and market access planning. This guide compares the US FDA and EU MDR approaches…
ISO 13485 certification is evidence of a medical device quality management system, not product approval. This article explains what the certificate covers, how it relates to FDA QMSR,…
ISO 13485:2016 remains a central quality management standard for medical device organizations. This article explains what it covers, how it supports regulatory compliance, and what changed with FDA…
US FDA device classification is the starting point for determining a device’s regulatory controls, premarket pathway, quality obligations, and postmarket duties in the United States. This guide explains…
ISO 13485:2016 remains the current international QMS standard for medical devices and has become more central to regulatory alignment after the FDA QMSR took effect in 2026. This…
CE certification for medical devices is the route to placing most devices on the EU market. This article explains the MDR pathway, required evidence, notified body involvement, transition…
ISO 13485 remains the core international quality management system standard for medical devices. In 2026, its role in the United States is more significant because FDA’s QMSR incorporates…
FDA’s former Quality System Regulation under 21 CFR Part 820 has been replaced by the Quality Management System Regulation. This article explains what changed, what still applies, and…
Risk classification determines how a medical device is reviewed, documented and monitored before and after market access. This article explains the core logic behind FDA, EU MDR, IVD…
CE IVD means that an in vitro diagnostic device is presented as conforming to the applicable EU requirements for placing it on the European market. In practice, the…
