News

AI For Cross Border Regulation

In this episode, Medtech Insight senior reporter Hannah Daniel interviews DJ Fang, COO and co-founder of Pure Global. Pure Global employs AI to assist device manufacturers in navigating global regulations. Their discussion covers clinical trials, how countries incentivize medtech innovation, and the Biden Administration’s tariffs on certain Chinese-made medical devices.

Published on:
July 25, 2024
Medtech Connect

Listen to the latest episode here.

Pure Global, Unlocking Global Markets for MedTech Companies.

Subscribe to newsletter
Subscribe to receive the latest blog posts to your inbox every week.
By subscribing, you agree to our Terms and Conditions.
Thank you for subscribing!
Oops! Something went wrong while submitting the form.
Read more

Latest News

Browse our news hub featuring company announcements, regulatory updates, and industry insights to keep you informed and ahead of the curve.

Regulatory Update
October 23, 2024

This week in medical device regulatory news: updated guidance on MDR requirements for legacy devices, China released new product guidelines, revised UK guidance on Conditional Marketing Authorizations, and more.

Regulatory Update
October 14, 2024

This week in medical device regulatory news: Brazil expedites registration of IVDs for mosquito-born diseases; new US FDA guidance on endosseous dental implants and abutments.

Regulatory Update
October 9, 2024

Our first round-up of October 2024 medical device regulatory updates includes new CLSI guidelines and an upcoming webinar in the US, new MDCG guidance documents in Europe, and new industry standards from the NMPA in China.

Regulatory Update
October 1, 2024

End of September 2024 brought updates from major markets: EU IVDR transition guidance for Class D IVDs, biocompatibility guidance from the US FDA, IVD family grouping regulations from Brazil, and more.

Contact us
Request information

Let's Talk,
Anywhere You Are.

Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.

Our closest representative will get back to you within 24 hours.
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

Latest Blog Content

Explore our collection of articles, success stories, and regulatory updates, designed to help you take your product global.

Blog Article
Language Challenges in MedTech Going Global and Our Solution

Multilingual documentation presents ongoing compliance and logistical hurdles for MedTech manufacturers. Transla.Ai is an industry-specific translation tool that can accelerate and streamline the translation process.

Medical device supply chain
Blog Article
Managing your medical device supply chain

The connection between supplier controls and business risks is becoming increasingly evident. In this article, we discuss perspectives on how to maintain a compliant medical device supply chain.

Blog Article
Brazil: Adapting to Evolving Regulatory Markets

Brazil aligns medical device regulations with global standards, including Europe and the US. Recent updates and international compatibility attract manufacturers.

Blog Article
AI in Medtech Brazil

AI is revolutionizing MedTech in Brazil, enhancing healthcare through process optimization and data-driven decisions. Pure Global ensures swift, compliant market introduction of innovative solutions.