All Blog Articles

Blog Article
Navigating Brazilian Markets: A Strategic Alliance with Pure Global

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

Blog Article
US Regulatory Insights: Pure Global Collaboration

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

Blog Article
Partnering with Pure Global Singapore

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

Blog Article
Untangling the Regulations of Health Tech

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

Blog Article
Perspectives on Using Outsourced Regulatory Services vs. the “DIY” Approach

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

Blog Article
Human Factors in Medical Device Manufacturing

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

Blog Article
Recall Management – A Necessary Evil of a Medical Device Company’s Post-market Responsibilities

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

Blog Article
Understanding Reimbursement-Related Payment is a Critical Piece of Medical Device Market Access Strategy

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

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