SaMD is software that performs one or more medical functions. While the software may be embedded in a piece of hardware (as is often the case) it's the software itself that performs the medical function. The international medical device regulators forum (IMDRF), of which the US FDA is a...
FDA Guidance The FDA published early January 2025, a long-awaited guidance aboutArtificial Intelligence Enabled device software functions. This guidance contains FDA's recommendations on how to document an AI-enabled device in marketing submissions. Almost 70 pages long, this guidance is a monster! C...
The Center for Devices and Radiological Health (CDRH) at the FDA is responsible for post-market surveillance of medical devices. If a device failure resulting in actual or potential serious injury or death is reported, the manufacturer of the medical device is required to investigate, determine ...
IEC 81001-5-1:2021, Health Software and Health IT Systems Safety, Effectiveness and Security, Part 5-1: Security — Activities in the Product Life Cycle. FDA Guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. ISO 27799: Health Informa...
DEARhealth has been clinically proven and validated at leading healthcare institutions around the world. DEARhealth is a software as a medical device and complies to the Medical Device Regulation CE – MDR class IIa | ISO27001 | NEN7510 | ISO13485 | FDA Enforcement Discretion ...
most importantly being recently new FDA guidance around the quality considerations around cybersecurity in medical devices, as well as updated guidance on the overall requirements on pre-market submissions for Software in a Medical Device (SiMD). We also discuss with our customers their experience usi...
(AI/ML) – Based Software as a Medical Device (SaMD)(“Modifications Discussion Paper”). FDA started its public discussion of AI/ML in 2019, as we blogged abouthere, with publication of an AI/ML-based SaMD discussion ...
(FDA), part of the Department of Health and Human Services, is the U.S. government agency with authority over the safety of food, drugs, medical devices, and radiation-producing equipment. To market any medical device or drug in the United States, you must have the approval of the FDA....
Going hand in hand with our mission to work on projects that improve people’s lives we partner with startups in the following industries to make an impact. Medical Devices We follow our proven agile development process to create secure FDA-cleared Software as a Medical Device (SaMD) and s...
The possibility of standalone software being a medical device has become a reality with the coming into force of new requirements in March of this year. Determining how the new requirements should be applied, however, is confusing. Guidance will be needed as well as new technical standards.年份...