Software Validation for Class I - Manufacture of a Part for a Medical Device

A

Anahita

#1
I work for a small manufacturing company that produces capacitors for medical and military customers.
I am not sure based on ISO 13485 (or FDA CFR 21.820) are we required to do software validation for our custom written softwares? Or the softwares written for the purpose of quality monitoring, ie. SPC software written in-house that are used as a part of production monitoring process.
I appreciate some feedback and help here!
 
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R

RMortby

#2
Hi Anahita,

Do you maintain a 13485 certified QMS?
If so, 13485 (7.5.2.1) requires that all software for production and service provision that affects the ability of the product to meet requirements is validated prior to initial use.
If your systems are not certified to 13485, it is going to be based on whether your medical customer is asking you to validate your software.
 
#3
I work for a small manufacturing company that produces capacitors for medical and military customers.
I am not sure based on ISO 13485 (or FDA CFR 21.820) are we required to do software validation for our custom written softwares? Or the softwares written for the purpose of quality monitoring, ie. SPC software written in-house that are used as a part of production monitoring process.
I appreciate some feedback and help here!
7.3.6 - Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use. Validation shall be completed prior to the delivery or implementation of the product.

See note 1
 
Last edited:
#4
Hi Anahita,

Do you maintain a 13485 certified QMS?
If so, 13485 (7.5.2.1) requires that all software for production and service provision that affects the ability of the product to meet requirements is validated prior to initial use.
If your systems are not certified to 13485, it is going to be based on whether your medical customer is asking you to validate your software.
If you are in Europe, you must validate a medical device that incorporates software according to 93/42/EEC whether you apply 13485 or not. It has nothing to do with customer requirements.
 
T

The Specialist

#5
If you are in Europe, you must validate a medical device that incorporates software according to 93/42/EEC whether you apply 13485 or not. It has nothing to do with customer requirements.

I don't think this is applicable to the OP.

I agree with RMortby
 
R

RMortby

#8
Anahita,

Please could you clarify whether the software is part of the device, or used in the manufacturing process?
My reading of your post led me to think that your software is being used as a process control and isn't part of the device?
 
A

Anahita

#9
Anahita,

Please could you clarify whether the software is part of the device, or used in the manufacturing process?
My reading of your post led me to think that your software is being used as a process control and isn't part of the device?
Thanks for responding to my question! :)

Just some clarification here, we don't produce a device, we are manufacturing a component (capacitor) that is later on used in a medical device by our customers.
We are based in US and ISO 9001 certified. We still don't have ISO 13485 but we are planning to apply for it.

We have 2 types of software: 1) The software that is not part of the device, it's for process monitoring purpose and is used as a quality metrics for process improvement.

2) We also write in-house software for running our machines and robots.

I was hoping as we are not making a medical device (only a part) we could be exempt of validating our software.

Thanks for all the help and feedback
 
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