topic Re: ISO 13485 Documentation validation in AutoCAD in AutoCAD Mechanical Forum

ISO 13485 Documentation

Anonymous — Tue, 29 Jan 2019 00:01:20 GMT

Is there any information regarding Autocad Software Validation process for
to cover ISO 13485 requirements?

Re: ISO 13485 Documentation validation in AutoCAD

cheryl.buck — Sat, 02 Feb 2019 00:38:11 GMT

Hi @Anonymous,

I see that you are visiting as a new member to the AutoCAD Mechanical forum. Welcome to the Autodesk Community!

If I am correct, ISO 13485 is related to Medical devices. Can you clarify what kind of validation you are looking for? How would you be using AutoCAD for this?

All the best,

Re: ISO 13485 Documentation

cheryl.buck — Mon, 04 Feb 2019 21:52:51 GMT

Hi @Anonymous,

I am checking back to see if you found the information you needed. Please post an update letting the community know.

All the best,

Re: ISO 13485 Documentation validation in AutoCAD

Anonymous — Tue, 05 Feb 2019 18:14:48 GMT

ISO 13485:2016 States:

4.1.6 The organization shall document procedures for the validation of the application of computer software used in the quality management system. Such software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application.The specific approach and activities associated with software validation and revalidation shall be proportionate to the risk associated with the use of the software. Records of such activities shall be maintained.

Can you share your software validation process?

Re: ISO 13485 Documentation validation in AutoCAD

cheryl.buck — Wed, 06 Feb 2019 16:58:11 GMT

Hi @Anonymous ,

Thank you for the information. As I understand the ISO requirement you noted, the validation is part of the procedural process, or plan, that you will need to set up, and is not provided by the manufacture of the software. It sounds like this will include a review process of the features and output of the software as needed for your use.

I found the following links that may shed some light on the process:

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm085281.htm

http://www.fda.gov/downloads/medica...onandguidance/guidancedocuments/ucm073779.pdf

Please let me know if this information helps.

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Please Accept As Solution any post(s) that answer your question or solve the problem.

All the best,

Re: ISO 13485 Documentation validation in AutoCAD

cheryl.buck — Fri, 08 Feb 2019 01:18:17 GMT

Hi @Anonymous ,

I am checking back to see if my post helped you with your question. Please post an update letting the community know.

If a post was helpful, Likes are always welcome.

Please Accept As Solution any post(s) that answer your question or solve the problem.

All the best,