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Congenius Whitepaper | How to develop SaMD

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.

You can download a sample extract of the whitepaper below, and to access a copy of the full whitepaper, simply get in touch via our website form, detailing your request in the message box.

For more information on the full breadth of our eHealth services, see here.

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t: +41 44 741 04 04


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