Clinical Evaluation Reports (CERs) are a crucial component in the regulatory submission process for medical devices, especially in markets like the European Union, where compliance with the EU Medical ...

Fraudulent data is becoming more common by the submission. So much so that the FDA recently published a press release reminding medical device manufacturers to scrutinize Third-Party Generated Data.” ...

J&J MedTech announced today the U.S. launch of the VOLT™ Plating System. The launch of this system represents an evolution in fracture management designed to improve stability, enhance performance, ...

Smith+Nephew and JointVue signed a co-marketing agreement for OrthoSonic 3D surgery planning technology. The technology allows surgeons using the Smith & Nephew Cori surgical robot to create ...

What are the essentials for compliant claims? How do you support and monitor claims in packaging and promotional content? Creating and following internal procedures is a strong defense. Navigating the ...

Fraudulent data is becoming more common by the submission. So much so that the FDA recently published a press release reminding medical device manufacturers to scrutinize Third-Party Generated Data.” ...

Modern interoperable systems, data centralization, and a wide-angle view of inventory and usage trends are providing hospitals to proactively switch from a “push” to a “pull” supply chain management, ...

MTI Regulatory Report 2024 data overwhelmingly suggests regulatory resources throughout the industry are being stretched. Time/Bandwidth is the top medical device regulatory challenge faced during ...

Five startups selected to participate in Memphis area Accelerator following The comprehensive 13-week go-to-market program is specifically designed to support medtech startups through essential ...

Largest U.S. Prospective Clinical Trial Ever Conducted Demonstrated High Compliance with the Flexitouch® System and Significant Improvements Across Study Endpoints MINNEAPOLIS, Sept. 25, 2024 (GLOBE ...

MedTech organizations need to focus on the human factor of change and achieve top-down alignment, buy-in, accountability, and clear communication along the way. MEDICA 2024 and COMPAMED 2024 trade ...

Modern interoperable systems, data centralization, and a wide-angle view of inventory and usage trends are providing hospitals to proactively switch from a “push” to a “pull” supply chain management, ...