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software tool validation for Medical Devices

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New Contributor

software tool validation for Medical Devices

Hello All,

I need to do TC software tool validation for the Medical Devices with the FDA/MRD standards [following regulation of: 21 CFR 820.70(i)] - looking for the example from someone who has done something similar or can share some opinions.

Thanks in advance and have a good day 🙂

Cheers, Bombsy.

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Community Hero

Re: software tool validation for Medical Devices

Hi Bombsy,

 

> Ill get back to you soon.

Don't get me wrong please, but I am afraid that I will not be able to be of much help here. Instead, I would recommend to contact Sales or Support via the https://support.smartbear.com/message/?prod=TestComplete form and hopefully guys will provide you with more relevant info.

 

Regards,
  /Alex [Community Hero]
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Community Hero

Re: software tool validation for Medical Devices

Hi,

 

https://community.smartbear.com/t5/TestComplete-General-Discussions/ISO-9001-certification-SmartBear... is the only relevant thread that I remember for the past dozen of years...

 

Regards,
  /Alex [Community Hero]
____
[Community Heroes] are not employed by SmartBear Software but
are just volunteers who have some experience with the tools by SmartBear Software
and a desire to help others. Posts made by [Community Heroes]
may differ from the official policies of SmartBear Software and should be treated
as the own private opinion of their authors and under no circumstances as an
official answer from SmartBear Software.
The [Community Hero] signature is used with permission by SmartBear Software.
https://community.smartbear.com/t5/custom/page/page-id/hall-of-fame
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New Contributor

Re: software tool validation for Medical Devices

Hello Alex,

Thank you for yuor quick replay - let me get familiar with this and Ill get back to you soon.

Have a good day,

Bombsy.

Highlighted
Community Hero

Re: software tool validation for Medical Devices

Hi Bombsy,

 

> Ill get back to you soon.

Don't get me wrong please, but I am afraid that I will not be able to be of much help here. Instead, I would recommend to contact Sales or Support via the https://support.smartbear.com/message/?prod=TestComplete form and hopefully guys will provide you with more relevant info.

 

Regards,
  /Alex [Community Hero]
____
[Community Heroes] are not employed by SmartBear Software but
are just volunteers who have some experience with the tools by SmartBear Software
and a desire to help others. Posts made by [Community Heroes]
may differ from the official policies of SmartBear Software and should be treated
as the own private opinion of their authors and under no circumstances as an
official answer from SmartBear Software.
The [Community Hero] signature is used with permission by SmartBear Software.
https://community.smartbear.com/t5/custom/page/page-id/hall-of-fame
================================

View solution in original post

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Contributor

Re: software tool validation for Medical Devices

Hi Bombsy....

 

What is not clear in your question is what you want to validate under the FDA regulations... Is it an an imbedded software on a medical device the medical device itself or the testing tool itself ?  Is it relevant to HIPPA regulations ? The tool is just a tool... How you build the automation depends  on you target... if there are confidentiality aspects, it's a matter of framework, the tool itself is irrelevant...  

 

Please clarify the purpose and what you are looking for... The tool itself will not test a device against FDA regulations... it<s the testcase you build that will do such thing...

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