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How to develop SaMD | Congenius whitepaper

Posted on by Congenius

As health care advances, software has become integrated widely into digital ecosystems that serve both medical and non-medical purposes. To help start-ups effectively navigate the challenges of developing Software as a Medical Device (SaMD) that meets the necessary regulatory requirements, our eHealth team here at Congenius has created a whitepaper that details how to develop SaMD in 10 clear steps.

There are three types of software utilised within medical devices:

  • Software as a Medical Device (SaMD): Software which is a medical device
  • Software in a medical device: Software which is integrated into a medical device
  • Software used in the manufacture or maintenance of a medical device

Our whitepaper focuses on type one – SaMD, and below are the 10 crucial steps that we explain in detail within the paper:

Step 1  |  Determine whether your Health Software is SaMD

Step 2  |  Classify your SaMD as required

Step 3  |  Define the appropriate Regulatory Pathway

Step 4  |  Align with the Essential Principles

Step 5  |  Use Standards to prove compliance

Step 6  |  Operate Controlled Design

Step 7  |  Consider Risk Management for Software, Cybersecurity & Use

Step 8  |  Consider Usability & Human Factors Engineering

Step 9  |  Build up your Technical Documentation (TD)

Step 10  |  Undertake effective Clinical Evaluation & Post-Market Surveillance

If you’re a start-up looking to place your SaMD on the EU and / or US markets, this whitepaper will provide you with a useful and comprehensive resource that walks through each important stage, to ensure you take the smartest route to device delivery and registration.

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