Need CDSCO registration for SaMD? Operon Strategist provides expert support for licensing, documentation, and complete regulatory compliance in India.
Software is increasingly playing a central role in healthcare, from diagnostic algorithms to clinical decision support tools and patient monitoring applications. When such software performs a medical purpose without being part of a physical device, it is classified as Software as a Medical Device (SaMD). In India, SaMD is regulated under a defined legal and regulatory framework to ensure safety, effectiveness, and accountability. Understandin
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 p
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 p