New Product Validation Plan example or template for a Medical Device

T

TIGERBILL

Hello, does anyone have a validation plan example or template for a medical device. The medical device is moving toward the transfer to manufacture stage and I want to ensure that all the required validation activities have been considered.
 

Stijloor

Leader
Super Moderator
Hello, does anyone have a validation plan example or template for a medical device. The medical device is moving toward the transfer to manufacture stage and I want to ensure that all the required validation activities have been considered.

Any Medical Device experts that can help?

Thank you!

Stijloor.
 

sagai

Quite Involved in Discussions
What we can do with such a broad question :bonk:

I even do not understand how any medical device can be developed in EU without having such fundamental principle on board. :frust:

br :bigwave:
Sz.
 
T

TIGERBILL

ok - let me ask the same question in a different way - does anyone have an example of a validation protocol, results and corresponding validation report that comply with FDA requirements. Of course you can sanatise for confidentiality reasons?
 

sagai

Quite Involved in Discussions
For SW you have to have a intended use based use case scenarios already defined in the phase of Design Input creation, and you have to run it after having your system level test and of course you shall document a test run like validation execution report as well as the final validation report, but I guess, its not a sw md.
br
Sz.
 
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