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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