The Global Handbook of Medical Device Regulatory Affairs offers key market opportunities by streamlining cross-border market entry for medical devices. It provides critical insights into ...
FDA's new medical device quality management rules align U.S. standards with global requirements and give inspectors new ...
Draft guidelines aim to align India's medtech software framework with global practices; industry seeks more clarity on AI/ML ...
In pain relief and physical rehabilitation, TENS-based therapies are widely used to support non-pharmacological treatment strategies. Reusable electrode pads enable patients to conduct multiple ...
When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...