What to include in a SaMD technical file

Your SaMD technical file should have clear documentation of appropriate planning, approval, activity and output to demonstrate that you have safely placed a device on the market. 

How you structure your technical file depends upon the specific requirements of the market and you may want to take into account the guidance of your conformity assessment body. Good practice guidance is also available through the International Medical Device Regulators Forum and notified bodies (see here for an example).  

All technical files for software as a medical device should include:

Device Description and Specifications

Detailed description of the device, its intended use, mode of operations, claims and benefits, a classification rationale, administrative information, device specifications, bill of materials, version history and identified predicate devices.

Information Supplied by the Manufacturer

Instructions for use including any user manuals, labelling and marketing materials.

Design and Manufacturing Information

Detailed design and manufacturing information including technical specifications and procedures for development, release and distribution, evaluation of commercial off the shelf and cloud software, cybersecurity controls and dataflows.

Risk Management File

The file should contain a risk management plan, risk assessments and evaluations, hazard analysis, consideration of real-world events from similar devices, and an indication of how risks have been reduced to an acceptable level.. 

Product Verification and Validation

The planned approach and results of device verification and validation testing. This should include functional and non-functional testing against performance and safety risks, usability and cybersecurity testing.

General Safety and Performance Requirements

An assessment of how the quality management processes and development activities meet essential general safety and performance requirements.

Clinical Evaluation, Post Market Surveillance and Clinical Follow Up

Documentation of the clinical evaluation approach including methodology and results of clinical studies, investigations, a review of state of the art and results from literature searches of potential safety risks. Post-market surveillance and clinical follow-ups including periodic safety update reports monitoring the device’s performance in the real world and an evaluation of the benefits, claims and risks of the device including a summary statement of clinical performance.

Depending upon the intended use and device characteristics, additional documentation may be required to ensure that the product technical file is a comprehensive and defensible record of the steps taken during the device lifecycle to manage potential risks and benefits.