SaMD

SaMD 인증 컨설팅

Software as a Medical Device(SaMD)

Software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.

The term “Software as a Medical Device” (SaMD) is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.  
 
NOTES: 
•SaMD is a medical device and includes in-vitro diagnostic (IVD) medical device.
•SaMD is capable of running on general purpose (non-medical purpose) computing platforms  
•“without being part of” means software not necessary for a hardware medical device to achieve its intended medical purpose;
•Software does not meet the definition of SaMD if its intended purpose is to drive a hardware medical device.
•SaMD may be used in combination (e.g., as a module) with other products including medical devices;
•SaMD may be interfaced with other medical devices, including hardware medical devices and other SaMD software, as well as general purpose software
•Mobile apps that meet the definition above are considered SaMD.

1. Medical purpose
The following two terms as defined in GHTF/SG1/N71:2012 (italicized below) identify medical purpose applicable to SaMD:

1.1 Medical Device
‘Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:
• diagnosis, prevention, monitoring, treatment or allevi­ation of disease,
• diag­nosis, monitoring, treatment, alleviation of or com­pensation for an injury,
• inves­tigation, replacement, modification, or support of the anatomy or of a physiologi­cal process,
• supporting or sustaining life,
• con­trol of conception,
• disinfection of medical devices,
• providing information by means of in vitro examination of specimens derived from the human body;

and does not achieve its primary intended action by pharmaco­logical, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means.
 
Note:  Products which may be considered to be medical devices in some jurisdictions but not in others include:
 • disinfection substances,
 • aids for persons with disabilities,
 • devices incorporating animal and/or human tissues,
 • devices for.in-vitro fertilization or assisted reproduction technologies.
 
1.2 In Vitro Diagnostic (IVD) medical device
‌ ‘In Vitro Diagnostic (IVD) medical device’ means a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes.
Note 1:  IVD medical devices include reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus or other articles and are used, for example, for the following test purposes: diagnosis, aid to diagnosis, screening, monitoring, predisposition, prognosis, prediction, determination of physiological status.
Note2:  In some jurisdictions, certain IVD medical devices may be covered by other regulations.
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‌1.3 Additional considerations for SaMD
   SaMD may also:
 • provide means and suggestions for mitigation of a disease;
 • provide information for determining compatibility, detecting, diagnosing, monitoring or treating physiological conditions, states of health,           illnesses or congenital deformities;
 ‌• be an aid to diagnosis, screening, monitoring, determination of predisposition; prognosis, prediction, determination of physiological status.
 
IMDRF/SaMD WG/N10FINAL:2013
GHTF/SG1/N70:2011

● 단독 소프트웨어(SaMD)의 준수 사항

– Human Factors Engineering
– IEC 62366에 따른 UI/UX Design
– Development with IEC 62304 compliance
– Medical Device Cybersecurity
– AWS and Azure Cloud Services and Analytics
– ISO 14971 Compliant Hazard Analysis
– Software Verification Testing
– Comlimentary Software Assessment

SaMD Quality Management Principles

● Medical device QMS principles allow for scaling of activities depending on the type of medical device; risk of the product to patients; 
size of the organization; technology or automation used to manufacture; and other factors that are determined by the manufacturer 
to control quality and maintain the safe and effective performance of the medical device.

● The manufacturing of SaMD, which is a software-only product, is primarily based on the development lifecycle activities 
often supported by the use of automated software development tools (build automation, use of source code management tools, etc.). 

These automated activities may in some cases replace discrete or deliberate activities (e.g., transfer of design to production) typically 
found in the manufacturing of hardware products.  However, the principles in a QMS that provide structure and support to the 
lifecycle processes and activities are still applicable and important to control the quality of SaMD.

● An effective QMS for SaMD should include the following principles:

○ An organizational structure that provides leadership, accountability, and governance with adequate resources to assure the safety, effectiveness, and performance of SaMD (outer circle in Figure 1);

○ A set of SaMD lifecycle support processes that are scalable for the size of the organization and  are applied consistently
 across all realization and use processes (middle circle in Figure 1); and

○ A set of realization and use processes that are scalable for the type of SaMD and the size of the organization; and that takes 
into account important elements required for assuring the safety, effectiveness, and performance of SaMD (innermost circle in Figure 1).

Figure 1: SaMD Quality Management Principles: Leadership and Organization Support, Processes, and Activities

● The three principles outlined above should not be considered independently as a separate series of processes in an organization. Instead, an effective QMS establishes a distinct relationship (see Figure 2 below) between the three principles as follows:

○ The governing structure of Leadership and Organization Support should provide the foundation for SaMD lifecycle support processes; and

○ The SaMD lifecycle support processes should apply across the SaMD realization and use processes.

Figure 2: Relationship between Quality Management Principles
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The concepts presented in this section relate to clauses 4 and 5 in ISO 13485:2003.‌