Ensure smooth and compliant SaMD Registration with US FDA. Operon Strategist provides expert regulatory consulting for 510(k), De Novo, and PMA submissions to help bring your medical software to market faster.

Software continues to reshape healthcare delivery, from clinical decision support systems to diagnostic algorithms and remote patient monitoring platforms. When software performs a medical function without being part of a physical device, it is classified as Software as a Medical Device (SaMD). In the United States, SaMD is regulated through a structured framework designed to ensure patient safety while supporting innovation. Understanding how Software as a Medical Device is regulated in the US is essential for business owners and decision-makers planning to enter or expand in the American healthcare market.

Website: https://operonstrategist.com/services/regulatory-approvals/samd-registration-with-us-fda/