Rising demand for advanced, cost-efficient medical technologies and the increasing shift by OEMs toward outsourcing is ...
Growth is fueled by rising demand for advanced diagnostic systems, home-based monitoring solutions, and robotic-assisted surgical devices, alongside surging chronic disease prevalence and an aging ...
Costa Rica has become a major global center for medical device manufacturing, driven by sustained export growth, expanding ...
More than 3 million Americans with pacemakers depend on these chemicals to live.
A medical device is any appliance, apparatus, software, material, or other articles, which may be used in isolation or combination (as defined by the manufacturer) by individuals for a medical purpose ...
The EU’s proposed orphan and breakthrough device designations would formalise accelerated regulatory pathways for high-need medical technologies, with significant implications for conformity ...
Key Takeaways - FDA’s 2026 guidance clarifies when digital health tools fall outside device regulation. Updated policies for clinical decision ...