Technical File for Medical Device Accessories

Q

QA_RA

Hello!

I'm relative new to the regulatory industry, I've recently completed a Technical file for my company's device. My manager requested another Technical file only for the accessories.

I'm not sure where to how to start a technical file for only medical accessories. Are there tech files made only for accessories?

Thank you in advance for your help!
 

somashekar

Leader
Admin
Hello!

I'm relative new to the regulatory industry, I've recently completed a Technical file for my company's device. My manager requested another Technical file only for the accessories.

I'm not sure where to how to start a technical file for only medical accessories. Are there tech files made only for accessories?

Thank you in advance for your help!
Accessories in there own right are also medical devices when placed in market independently. They will carry a device label and your technical file for this will be pretty much on the same lines as the device itself, just scaled down to the requirements of the specific accessory.
As you have a completed file for the device, it must be no great challenge to put in place one for the accessory.
 
S

SteveK

No problem with what Somashekar has indicated. I would just point out to your manager that TFs require reviewing by NBs. The more TFs, the more the individual review cost. In our case the last TF review cost circa $3000.:2cents:

Steve
 
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