SmartAlpha is an independent, fast-growing company with restless top-notch talents.
We are a team of clinicians and engineers mastering what we call “Medical Artificial Intelligence”. When we started to bring our talents together, from the first day, we promised to invent smart and unconventional solutions for healthcare.
In addition to dedication to safety, health, and environmental protection requirements of medical device regulations and continuous conformity to ISO 13485 and ISO 62304 standards, we took an oath that we will always be aligned with these set of ethical principles:
Good Machine Learning Practice (GMLP)
The principles identified jointly by The U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), guides us for safe, effective, and high-quality medical devices that use artificial intelligence and machine learning (AI/ML).
Good Clinical Practice (GCP)
GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. We strictly follow the associated standards to provide the highest-level ethically credible products.
Declaration of Helsinki
Ethical Principles for Medical Research Involving Human Subjects developed by WMA (World Medical Association), first released in Helsinki, is a statement of ethical principles which guides us on validating our technology through clinical studies involving human subjects, including research on identifiable human material and data.