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May 16, 2024

On-Demand Webinars | Medical Device Registration in worldwide countries

New to our On-Demand webinar series: Canada. Watch our On-Demand webinars to learn more about the regulatory framework in Asia-Pacific, Latin American countries and Canada, presented by our regulatory affairs associates around the world.
April 30, 2024

Ensuring Data Integrity in Medical Device Submissions: FDA's Call to Action

April 02, 2024

The Role of Biological Risk Management in Medical Device Development

The biological evaluation is part of the conformity assessment of a medical device with the requirements of Regulation (EU) 2017/745. Read in this blog about the role of Biological Risk Management in Medical Device Development.
March 18, 2024

Q&A: Chinese Medical Device Regulations NMPA

The most common questions and answers about market access in China. In this whitepaper 21 questions will be answered about the Chinese Medical Device Regulations NMPA. Everything you need to know about Medical Device Registration in China.
March 06, 2024

Countdown to Compliance: Safeguarding Your EU Market Access in Less Than 100 Days – Stay on Track!

As the May 26, 2024, deadline for EU MDR transition approaches, regulatory compliance becomes paramount.