What is SaMD?
SaMD stands for Software as a medical device. Software as a medical device is any software intended to be used for one or more medical purposes that perform the functions of a medical device without being a part of a hardware medical device. It is important to note that SaMD may interact with other medical devices that are hardware based and be used in conjunction with other medical devices, but to fall under the SaMD categorization the software must run on general computing platforms (often mobile devices). Some examples of software as a medical device include but are not limited to the following:
- Treatment planning software that supplies information used in a linear accelerator;
- Software that computes risk scores and aids in diagnosis of colorectal cancer based on physician input parameters and biopsy images; and
- Software that allows a smartphone to view images from a magnetic resonance imaging (MRI) medical device for diagnostic purposes.
For more information about SaMD this link to the FDA website may be helpful, click here.
Software as a medical device is an area that is increasingly expanding with the advancement of technologies in the digital workspace. With this expansion, regulators are also increasingly looking to ensure that the technologies comply with relevant standards and regulations.
Because SaMD developers are considered medical device manufacturers, they must comply with appropriate regulations. This includes the 21 CFR 820 quality system regulation for the US FDA, and ISO 13485 quality system regulation for markets outside the US. There are also standards and guidance documents specific to SaMD that must additionally be considered, along with the general medical device manufacturer requirements.
This includes (but is not limited to): Various guidance documents published by the FDA in the US, the international standard IEC 62304 for software development lifecycle processes, and guidance documents developed by the International Medical Device Regulators Forum (IMDRF).
SaMD Template Package
Maintaining an efficient and effective quality management system is just as important with SaMD as it is with hardware alone or combination medical devices. As the software industry is rapidly growing and advancing, regulators are also working to provide updated regulations and guidances relevant for the developing industry. With this increased burden for regulation compliance, it can be an overwhelming task trying to ensure that your QMS as a SaMD developer covers all the bases.
To help alleviate some of the stress and burden of creating a QMS fit for SaMD, Rook Quality Systems has developed a complete SaMD documentation template package covering the requirements necessary to maintain an efficient and effective QMS for SaMD. This template set incorporates the regulatory requirements from the most recent FDA guidances on software, as well as those regulatory requirements from the international standards ISO 13485 and IEC 62304 specific to software as a medical device. This template set can also be utilized in combination devices that have both software and hardware components.
The SaMD templates that the Rook Quality Systems team has developed are now available through our tried and true partner, Greenlight Guru. Look to Rook to inquire about this helpful template set!