If you’re looking to market your medical device, there are many tasks to complete.
The deal will help J&J speed up its entry into the robotics market.
The explosion of this technology is changing patient interaction with physicians, hospitals, and the entire healthcare landscape in general.
The deal will help strengthen the Edwards portfolio of smart monitoring technologies.
The agency’s intent is to decrease regulatory burden while promoting patient access to products.
Most devices are still developed in a moment of need and not in advance like adult devices.
The success of these technologies also relies on simplification to target certain patient populations, ensuring secure data transmission, and that operational models are built to make effective use of the data.
The device approvals address critical patient need.
The device has been exhibiting a lockup condition during patient use, leading to potential serious injury or death.
With just over a year remaining before the EU MDR and IVDR regulations go into effect, many in the medical device industry are shifting their compliance efforts into high gear—a somewhat tedious task given the industry is still waiting on functional specifications for Eudamed.