Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...
In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...
The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical technologies. This article examines the 2024 guidelines from the U.S. Patent and ...
Medical Device Network on MSN
FDA announces regulatory exemptions for 'non-medical grade' devices
FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less ...
The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...
The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD). The guidance is presented as representing the FDA's current thinking on ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up to receive our free e-Newsbulletins Some states have laws and ethical rules regarding solicitation and ...
The Food and Drug Administration has finalized a regulation that provides a less-burdensome path to market for certain hardware and software products used with medical devices, according to an FDA ...
Medical device manufacturers are increasingly implementing integrated mobile software and device applications to automate the inventory management process. By doing so, companies can better track ...
The latest update to the Federal Drug Administration (FDA) for medical device cybersecurity mandates the development of a software bill of materials (SBOM). This provision can be a significant ...
Results that may be inaccessible to you are currently showing.
Hide inaccessible results
Feedback