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.