Regulatory Open Forum

Hello Regulatory Folks,

Need advice on legacy SW:

1) How would you convert non regulated SW into regulated SW? What are the steps need to be taken to make sure that the legacy SW is now an FDA compliant SW. Background: My organization was developing non regulated SW and now we find out that we have to use these developed SW in class II Medical device? Please advice
2) All the development documentation is on JIRA, Confluence (Tools). My thinking is that both of these tools are not in compliance with part 11. What can We do to make sure that both the tools are in compliance with FDA. Because I do not want to recreate all the documentation.

Please let me know if there is any guidance available on how to convert the non regulated SW to regulated one.

Thanks,
Bhupinder

------------------------------
Bhupinder Singh
San Jose CA
United States
------------------------------

Take a look at IEC 62304:2006/AMD 1:2015.

The amendment is intended to add requirements to deal with LEGACY SOFTWARE, to assist manufacturers who must show compliance.

Regards,

John Beasley, RAC (US)
www.medtechreview.com


Original Message------

Hello Regulatory Folks,

Need advice on legacy SW:

1) How would you convert non regulated SW into regulated SW? What are the steps need to be taken to make sure that the legacy SW is now an FDA compliant SW. Background: My organization was developing non regulated SW and now we find out that we have to use these developed SW in class II Medical device? Please advice
2) All the development documentation is on JIRA, Confluence (Tools). My thinking is that both of these tools are not in compliance with part 11. What can We do to make sure that both the tools are in compliance with FDA. Because I do not want to recreate all the documentation.

Please let me know if there is any guidance available on how to convert the non regulated SW to regulated one.

Thanks,
Bhupinder

------------------------------
Bhupinder Singh
San Jose CA
United States
------------------------------

Thanks John!

I will take a look at IEC 62304/ AMD 1:2015

Appreciate your time!

Bhupinder

------------------------------
Bhupinder Singh
San Jose CA
United States
------------------------------

Original Message:
Sent: 19-Sep-2017 13:52
From: John Beasley
Subject: Legacy SW

Take a look at IEC 62304:2006/AMD 1:2015.

The amendment is intended to add requirements to deal with LEGACY SOFTWARE, to assist manufacturers who must show compliance.

Regards,

John Beasley, RAC (US)
www.medtechreview.com


Original Message------

Hello Regulatory Folks,

Need advice on legacy SW:

1) How would you convert non regulated SW into regulated SW? What are the steps need to be taken to make sure that the legacy SW is now an FDA compliant SW. Background: My organization was developing non regulated SW and now we find out that we have to use these developed SW in class II Medical device? Please advice
2) All the development documentation is on JIRA, Confluence (Tools). My thinking is that both of these tools are not in compliance with part 11. What can We do to make sure that both the tools are in compliance with FDA. Because I do not want to recreate all the documentation.

Please let me know if there is any guidance available on how to convert the non regulated SW to regulated one.

Thanks,
Bhupinder

------------------------------
Bhupinder Singh
San Jose CA
United States
------------------------------