Software as Medical Device Start-Up Template Package
If you are a start-up company developing an app or health software that could have an intended medical purpose, then you will need to consider the adoption of the recognized standard for Medical Device Software EN 62304: 2006+A1: 2015. The standard guides you to output a number of documents that can be used as Verification and Validation of the software in preparation for submission to the notified bodies or the FDA etc.
Pharmi Med has prepared these templates to help start-up companies who traditionally do not have Medical Device experience but usually from a Software Engineering background but need to penetrate the market. We have reduced the burden by creating these templates for your engineers. If you need further assistance in the regulatory framework of submissions please contact us here
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Simplimedica has prepared these templates to help start-up companies who traditionally do not have Medical Device experience but usually from a Software Engineering background but need to penetrate the market. We have reduced the burden by creating these templates for your engineers.
The purpose of this document is to document the transformation of the software requirements specified in the Software requirements document for the software system into an architecture that describes the software’s structure and identifies the software items.
Software Design Review
The purpose of this document is to document the outcomes of the final review meeting for the Software system
Software Detailed Design Doc
The purpose of this document is to specify the design details for the software system as described in the software development plan, software requirements document and software architecture document.
Software Development Plan
The purpose of this document is to detail the implementation of the software development plan.
Software Maintenance Plan
The purpose of this document as per item 6.1 in EN 62304, shall contain the software maintenance plan for the software. This plan shall detail how the activities and tasks of the maintenance process will be carried out.
The purpose of this document is to detail all the software system requirements that must be fulfilled during, and as a result of, the development of the software system
Software Requirements Trace Matrix
The purpose of this document is to trace the Software Requirements to the Software Architect component and to the Software Design test
Software Risk Management
The purpose of this document is to outline the Risk Management process carried out for the software system
Software Safety Classification
The purpose of this document outlines the medical device software has been developed in accordance with EN 62304 + A1, which requires each software system to be assigned a software safety class (A, B or C) “according to the risk of harm to the patient, operator, or other people resulting from a hazardous situation to which the software system can contribute in a worst-case-scenario”.
This document will define the software safety class for each software system in the medical device software in accordance with section 4.3 of EN 62304 and the provide the rationale on which the classification was based.
In accordance with EN 62304 + A1, The purpose of this document is to declare any identified SOUP (Software of Unknown Provenance) items being used (including standard libraries) in the medical device software.