Connect and stay on top of the MedTech regulatory landscape globally.

Two early FDA Warning Letters from post-effective QMSR inspections directly cite incorporated ISO 13485:2016 clauses. The cases connect risk management to design changes, intended use, suppliers, complaints, rework, CAPA, environmental controls, and software validation—and give manufacturers a concrete evidence map for inspection readiness.

Two EU delegated regulations expand separate MDR exemptions for specified well-established technologies. The changes affect clinical-investigation decisions for listed implantable and Class III devices and per-device technical-documentation assessment for listed Class IIb implants, without removing broader MDR evidence or conformity-assessment duties.

Final IMDRF N90 defines five principles and three connected elements for medical device software PCCPs. It creates a common design framework, not automatic authorization: manufacturers must still verify acceptance, scope, and implementation requirements in every market.

The Malaysian Ministry of Health (MOH) and Medical Device Authority (MDA) announced the phased implementation of a Hologram Security Label for registered medical devices. The initiative aims to strengthen post-market surveillance, improve product traceability and help medical device and IVD manufacturers, healthcare professionals and consumers identify registered products and combat counterfeit and unregistered medical devices.

Pure Global has launched a flat-fee pricing model for medical device registration that simplifies global expansion across 13 key markets. With AI-assisted dossier preparation and in-country representation included, manufacturers can easily plan their market access budgets.

Pure Global has launched AI Builder, a proprietary automation platform that cuts medical device dossier preparation time by up to 75%. The launch introduces a new flat annual pricing model and marks a major step toward on-demand, AI-powered global medical device registration.

Pure Global's new CTO, Ran Chen, brings over a decade of experience in building and scaling machine learning products.

Pure Global is proud to announce its inclusion in the China Business Service Providers (BSP) directory on the International Trade Administration website.