Software in Medical Devices, by MD101 Consulting

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New IMDRF document on Medical Device Software

The IMDFR organization published in January 2024 a new document on Medical Device Software: Considerations for Device and Risk Characterization
Say briefly, this document is a gem!

The scope of this document is Medical Device SoftWare (MDSW). It includes (Software as a Medical Device - SaMD) and embedded software (Software in Medical Device - SiMD).
The Main virtue of this document is to [identify] common considerations regarding device characterization and risk characterization to provide a harmonized lens and common language for improved transparency and consistency between stakeholders.

The main idea behind this document is to describe and characterize a MDSW in a formal and comprehensive way, in order to perform software risk and benefit management and in a better way. Better than when such characterization isn’t performed.

The document contains two main sections:

  • One on software characterization: intended use, intended purpose, device description, device objectives, context of use, software functions,
  • One on risk characterization: risk identification, risk estimation, risk categorization.

The document also contains a tiny section on change management in device characterization. With a discussion on the degree of autonomy of change management for software. I pinpoint this section because, contrary to other sections, I’ve never seen any document (regulatory guide or standard) discussing this topic this way.

Tables in appendixes B and C

Appendix B Characterization Feature Summary Table contains all what you need to check to ensure that you describe your MDSW in a formal and comprehensive manner.
Use it as a checklist in some early design review.

Appendix C Example Considerations to Understand Software Hazards Associated with Device Design and Intended Use contains a list of questions to ask when you want to identify an evaluate MDSW risks.
This table can complement advantageously the annex A of ISO 24971. Annex A of ISO 24971 isn’t focused on MDSW. This Appendix C is.
Just add it to your existing template of SW risk management plan and risk assessment report.

No concept present in this document can be considered as a brand new idea. But it has the virtue to gather in a single document several ideas coming from various sources (standards, regulatory submission templates, guides...).
At the risk of repeating myself, this document is a gem!
Read it and make your own judgment.

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