Validation of Class I Metal Medical Device

P

Philip1983

#1
Hello to everybody at the Cove

I am looking for some advice about a validation of a Class I Medical device.

It's a metal part which is CNC turned and after a heat treatment and then surface treatment (electro polished).

For the CNC part we are planning to do a OQ and PQ with MFK, SPC with retrospective IQ because the machines are installed since a long time.

What would you suggest for the heat treatment and surface treatment?

I am really lost and everybody thinks I am the big specialist and knows what to do. :-(
I only have big experience with sterilizer validations for class III devices.

Thanks for any help you can give me.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hello and welcome to the Cove :bigwave:

From your post it's hard to tell which is your target market and what regulations / standards apply to your device.

It's not obvious that a class I device must go through process validation.

Cheers,
Ronen.
 
P

Philip1983

#3
Thanks. I was already at the Cove some time ago but didn't remember my login data.

I was just told ISO 13485. I will check again with my boss. Perhaps I can get some more helpful infos from him.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Thanks. I was already at the Cove some time ago but didn't remember my login data.

I was just told ISO 13485. I will check again with my boss. Perhaps I can get some more helpful infos from him.
Hi,

Assuming it's not a sterile device.

a. If this device comes under ISO 13485 then process validation is applicable.
b. Most likely heat treatment requires a full process validation.
c. Electropolishing validation also makes a lot of sense.
d. I don't think a retrospective IQ should be a problem as long as you don't cut corners and ensure everything is properly documented.

There's some good guidance in ISO/TR 14969 (if you have it) and in GHTF/SG3/N99.

Cheers,
Ronen.
 
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