Software as a Medical Device(SaMD)

Get your SaMD products faster to the market with our full spectrum SaMD SOP & Execution services. Compliance Group is retained by some of the biggest Medical Devices companies to expedite end to end execution of SaMD life-cycle

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SaMD
What is SaMD?

What is SaMD?

By definition, Software as a Medical Device(SaMD) are applications intended for medical use without use of hardware (International Medical Device Regulators Forum (IMDRF) ). These are not software (like embedded software) fixed inside a device. SaMD can include software that can control/interfere with the hardware and/or medical devices and also mobile / wearables that meet the IMDRF definitions.

SaMD vs SiMD

Do you have clear definitions and pathways for SaMD and Software in Medical Device (SiMD)? The SiMD category is often confused with SaMD and has different pathways compared to SaMD. It is generally considered that software that helps run a medical device is SiMD. However, a lot of SiMD software share characteristics of SaMD – for example, a mobile app, which is almost always associated with SaMD can actually be SiMD.

Right from identifying the correct type of Software to ensuring an expedited risk-based execution of end to end processes, Compliance Group is your trusted partner in bringing SiMD and SaMD software faster to market

SaMD Quality Management System

SaMD Quality Management System

SaMD manufacturers have to implement a Quality Management System setup based on best practice principles shown in the figure. Setup lifecycle support processes that are scalable for the size of the organization and ensure a consistent application of all processes.

How can we help?

Contact us for a free consultation and / or a part-time or a full- time engagement for a compliant and expedited execution of your SaMD endeavours. Our expert resources can help with execution of the following:

  1. Consulting to setup full QMS
  2. Staff Augmentation / contract resources to help with execution of processes - requirements management, design, development, verification and validation, deployment, maintenance, and decommissioning of the product
How can we adopt SaMD

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