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.” ...

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 ...

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 ...

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 ...

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 ...

Taking a bare-minimum approach to meeting the eIFU requirements of EU MDR could mean missing an opportunity to improve transparency in healthcare. Here’s how to use eIFU to provide stakeholders with ...

AdvaMed has reported that its member companies have provided $26.8 million in medical supplies, along with $4.1 million in cash donations.

Supply chain challenges and the move to advanced manufacturing are two key issues affecting the Medtech industry. On November 7-9, MedTech Intelligence will be hosting the MedTech Advanced ...