Ameing for Asia

Companion Diagnostics Regulations Evolving in Asia

By Ames Gross, Pacific Bridge Medical

Companion diagnostics (CDx) play a pivotal role in personalized medicine—one of the fastest growing areas of medicine. Regulation of CDx is fairly well established in western countries, but the east is not far behind. Here we look at current and on the horizon regulatory guidances and directives for CDx manufacturers seeking to enter the Asian markets.

From TikTok Trends To Counterfeit Drugs:
How Better Labeling Systems Can Help

By Bob Tilling, Kallik

Bob Tilling, VP of Global Sales at Kallik, delves into dupe culture and its link to counterfeit drugs, and explains how developments in label management can foil illicit traders.

Ask the Expert:
Benefits and Challenges of the eStar Submission Process

By MedTech Intelligence Staff

Companies must now electronically submit all FDA 510(k) submissions using the eSTAR platform. Dr. Dhriti Roy, vice president of Regulatory Affairs Transformation at Essenvia and faculty at Oxford University’s MedTech innovation platform, highlights the benefits and challenges of eSTAR, as well as processes and tools companies need to adopt as they transition to this new submission process.

EU MDR:
Ensuring Labeling Compliance

By Warren Lesack, Loftware

EU MDR requires significant reforms to the device labeling process. Manufacturers must ensure that identifiers are correctly applied to products, and that key data elements and formats are accurate. In addition, manufacturers need to have access to centralized data, audit tracking, robust security controls, eSignature capabilities and strong workflow management to ensure compliance.

Biomedical Implant Design:
Researchers Uncover Culprit Behind Rejection

By MedTech Intelligence Staff

Researchers found that mechanical stress caused by implants leads immune cells to activate RAC2 and other proteins, which then summon additional immune cells, including types that can combine to attack a large invader. These findings may help improve the design and safety of implants.

How redesign can help meet sustainability demands
for medical devices

Redesign using Design for Environment principles can help medtech companies meet sustainability demands for their devices. See how to analyze and use eco-smart designs that account for sustainable materials, product durability, and improved energy efficiency.

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