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Medical Device Software: From Requirements to Certification.

Noemi Giordano¹, Samanta Rosati¹, Gabriella Balestra¹

¹Department of Electronics and Telecommunication, Politecnico di Torino, Italy.

Studies in Health Technology and Informatics

|October 23, 2023

Summary

This summary is machine-generated.

Developing compliant Medical Device Software (MDS) requires a regulatory pipeline. This process integrates requirements, risk assessment, and effectiveness analysis from concept through implementation for EU certification.

Keywords:

MDS certification Medical device software

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Area of Science:

Health Informatics
Regulatory Science
Software Engineering

Background:

Healthcare software is increasingly prevalent, yet often overlooks its status as a medical device.
Compliance with the EU Medical Device Regulation 2017/745 is critical for software manufacturers.
Failure to adhere to regulations can impede market access and patient safety.

Purpose of the Study:

To propose a comprehensive pipeline for developing certifiable Medical Device Software (MDS).
To ensure MDS development aligns with the EU Medical Device Regulation 2017/745 requirements.
To outline key phases for regulatory compliance throughout the MDS lifecycle.

Main Methods:

Development of a structured pipeline for Medical Device Software (MDS).
Integration of requirements elicitation, risk assessment, and effectiveness analysis.
Parallel preparation of the technical file alongside MDS design and implementation.

Main Results:

A proposed pipeline facilitates the creation of regulatory-compliant MDS.
Key phases identified for successful certification under EU MDR 2017/745.
Emphasis on parallel processing of development and technical documentation.

Conclusions:

The certification process for MDS begins at conceptualization and continues through design and implementation.
Adopting a structured pipeline ensures adherence to the EU Medical Device Regulation 2017/745.
Proactive integration of regulatory requirements streamlines the path to market for healthcare software.