Medical Device Internal Test Certificate Example

[QACen]

Hello,

We manufacture medical devices and a customer is requesting for documentation of the results of our internal testing prior to shipment. I assume that this would be a test certificate or test confirmation type of document. Can anyone share a template?

Thanks!

 

[Marc]

What do you use in-house to document in-house testing such as final acceptance testing?

 

[QACen]

Yes. I know I can use information from those documents to summarize for the customer. I was just curious to understand what experienced folks in the industry do for the customer. What goes in that document? What are some things that should be listed? The customer was not specific.

 

[Marc]

I'm not aware of any specific document, but then again - Every company and every product would be different. If you do final acceptance testing I would think that a copy of that report would be sufficient.

You will find a lot of folks here in posts like this will also say you should ask your customer directly specifically what they want. Their generically asking for something like "...documentation of the results of your internal testing prior to shipment..." would be to me final acceptance testing. Ask them if that is what they want, and if they're "not sure" or something like that, offer them a copy of your final acceptance test report(s).

 

[Pelau]

Actually, they want a certificate of conformance - with the proof with the measurements and the method of testing. Concurs with other comments

 

[SteveK]

Attached is the type of template I use for our customers, when requested. It shows an example of a particular standard (in addition to QMS references) the item complies with and was tested to, as per details in the Technical File.

This format has been accepted over many years in our case thus far.

Hopefully this helps.

Steve

 

[yodon]

I'm curious why such a cert would be necessary. As a medical device, it's in a regulated industry and the regulations require that the production be performed in a manner that (reasonably) ensures the product made will comply with its specifications.

I guess if it makes the sale, it's worth it but would customer education be possible?

 

[Pelau]

In addition to the cert...the proof of the actual specifications were achieved and the inspection or tests carried out.