Compliance with Standards? When a standard is updated/revised

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#1
If our Essential Requirements states we tested to a certain standard xyz:2010 and passed in our original device approval and we are making a substantial change to the device, if the standard was updated to xyz2020 in the interim Do we:

1) list compliance with the xyz2010 standard?
2) Have to perform new testing to the xyzx2020 standard?
3) when new versions of the standard are updated how does that impact our testing requirements?
 
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indubioush

Quite Involved in Discussions
#2
Instead, do this:
1) Perform a gap analysis (documented) between 2010 and 2020 versions to determine what needs to be done to comply with the new version.
2) Using your change control process, determine what testing needs to be repeated because of the design change.
3) Use information from items 1 and 2 above to test your device so that you are compliant with the latest version of the standard.
 
#3
1) List compliance with the xyz2010 standard - You can do this is if the standard is still in effect (i.e. within transition period) and/or the countries you market to has not yet adopted the new standard. But concept of "generally acceptable state of the art" is interpreted as taking into account the latest version of the standard.
2) Have to perform new testing to the xyzx2020 standard? - per 1) above, if the standard has expired (end of transition period) and you want to ship product - you will have to demonstrate conformity to xyz2020 - this can be done per indubioush's reply above - gap assess -> determine testing scope -> test
3) when new versions of the standard are updated how does that impact our testing requirements? - From a design controls perspective, sa change in standards may not undo your existing verification/validation status. As part of your external origin document control, you should maintain a procedure for reviewing changes, assessing impact to your products and taking appropriate action.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#4
Thanks! I performed a GAP analysis using the change description from each new standard as a guide. Worked out well for our sub.
 
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