SaMD Diabetes Software Experts
Software as a medical device has its own development needs and regulatory guidelines. Find out what qualifies as SaMD, the best practices for developing it, and how to do so in line with regulatory guidelines.
Software as a medical device has its own separate definition according to most regulatory bodies. Find out if your medical technology qualifies as SaMD in Part I of our software as a medical device series.
Remote patient monitoring is a growing market with applications in outpatient and inpatient hospital settings. For diabetes software and medical device companies, this niche is ripe with opportunities for product development.
Experts agree that FDA approval for CGM use in hospitals is less than a year away. Find out why it is worth banking on this prediction and what opportunities exist for innovative medical technology companies.
IEC 62304 is an important standard for the planning, development, and launching of safe medical software and software-based medical devices. Find out how this functional software lifecycle standard helps deliver safe medical tech that aligns with national regulations.
ISO 14971 is a vital tool for the design and development of safe and effective medical technology software. Find out what this standard consists of and how you can put it to use to streamline your risk management process.
SaMD Diabetes Software Experts
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