The software has become an integral part of almost all facets of life. It has pronounced usage in the healthcare and medical field. There are three types of software related to medical devices.

  1. Software as Medical Device (SaMD)
  2. Software that is integral to a Medical Device
  3. Software used in the manufacture or maintenance of Medical Device

SaMD is software which on its own is a device employed for a medical purpose. The International Medical Device Regulators Forum (IMDRF) defines SaMD as ‘software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.’ The software is built to respond to an algorithm that would produce a result or output based on input and reference data.

There is a rapid increase in the development of SaMDs and some examples of such devices are:

  1. Software intended to diagnose a condition using an accelerometer in a digital camera
  2. Software that allows MRI or other medical imaging to be viewed on mobile devices
  3. Software that performs image processing to detect cancer
  4. Treatment planning applications that streamline information
  5. Software that controls an installed medical device
  6. BMI and body fat calculators, and heart rate monitors

The distinct features of a ‘Software as Medical Device’ bring about the need for standardized principles to enable patient safety and accurate diagnosis. One major risk with a SaMD is largely related to inaccurate or erroneous output that could affect the clinical management of a patient.

The IMDRF and SaMD

The IMDRF formed the SaMD Working Group (WG) to provide guidance for safe and effective SaMD development. The WG lays emphasis on collecting and presenting robust clinical data (through various means) at the premarket approval and postmarket stages so that the SaMD is continually able to provide the required technical and clinical outcomes and the risk of inaccurate or erroneous output is significantly reduced through design changes.

The guidance document on Clinical Evaluation of SaMD details the process of clinically evaluating SaMD, the steps of which are illustrated below.

SaMD – Definition statement

A SaMD manufacturer is expected to generate evidence of the product’s analytical, technical and clinical validation in addition to proving a concrete clinical association between the output and intended clinical condition. This will enable the manufacturer to draft the ‘definition statement’ that outlines the purpose of the SaMD and to categorize the device as per the standard regulatory framework.

Once the product is introduced into the market, the manufacturer is responsible for collecting real-time performance data to ensure continued safety and effectiveness. This will help in rectifying errors and improving the device’s efficiency.

SaMD CER – Independent Review

It is highly important that high-risk SaMDs are reviewed independently. The importance of the Independent Review of the Clinical Evaluation corresponds to the category and risk levels of the SaMD. Independent review of certain low-risk SaMDs may be less important and can be ‘self-declared’ by the manufacturer. An ‘Independent reviewer’ should preferably be someone who has not been involved in any stage of SaMD development and has no benefits from the product’s success. The reviewer should be capable of objectively assessing the SaMD for its intended purpose against the findings obtained from the clinical evaluation process.

SaMD – Continuous learning

Post-market real-time performance monitoring will help in the continuous learning across the product’s lifecycle. New information gathered from real-time performance may lead to significant corrective measures, design changes and other modifications that could improve SaMD performance, safety, and efficiency.

Manufacturers of SaMDs can utilize the expertise of reliable third-party consultants, like Elexes, who can assist in the process of creating Software Definitions, Clinical Evaluation Reports, independent reviews, and continuous learning pathways and ensure a safe and high-quality end product.

Posted in
Blog ISO 13485

Elexes Team

Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.

Post a comment

Your email address will not be published.