Brazil stands as Latin America's largest medical device market, regulated by ANVISA with recent updates to accommodate new technologies and international harmonization.

Combining expert regulatory guidance with cutting-edge clinical laboratory support to streamline the FDA approval process.

With a population of 5+ million, Singapore has the highest GDP per capita in Asia, according to Trading Economics.

Exploring the evolution from wellness apps to regulated medical devices, highlighting the significance of global compliance and security.

Addressing product development and regulatory hurdles, medical device and IVD manufacturers are advised to assess capabilities and seek external expertise for market success.

An overview of essential human factors engineering standards and guidance for global medical device manufacturers.

Navigating the complexities of medical device recalls requires a robust management plan and clear communication strategies.

A guide to regulatory clearances, global reimbursement strategies, and the essential PICO approach.