Software in Medical Devices, a blog by MD101 Consulting

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ISO 13485 201X DIS2

The DIS2 (2nd draft version) of the next ISO 13485 was released in february.
It is published for comments on BSI draft review system website. Go to this website and search for 13485 to have a look at this draft.

Compared to what we said in the last article about ISO 13485:201X, there aren't fundamental changes for software.
Requirements about software are still present in this draft version:

  • 4.1.6 on the validation of the application of computer software used in the quality management system,
  • the reference to IEC 62304 in 7.1 Planning of product realization,
  • 7.3.9 on Design and development records,
  • 7.6 on Control of monitoring and measuring equipment.

Some notes where the word "software" occurred were withdrawn. These notes aren't requirements, thus no requirement about software documentation and validation was withdrawn.

A change of wording was made in 7.1:

  • The reference to IEC 62304 was: See IEC 62304 for guidance related to software life cycle processes.
  • It became: For information related to software life cycle processes see other documents, for example IEC/ISO 62304.

The same change was applied to the wording of the reference to ISO 14971 for risk management.

This new wording leaves the door open to other standards, like standards about the validation of software used in regulated processes.

To sum up, this new draft version confirms that ISO 13485 strengthens requirements about software documentation and validation. Be it in a medical device or in a process in the scope of the QMS of a medical device manufacturer.


Next time, we'll see what's behind the publication in burst mode by the FDA of guidances about mobile apps.



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