What certifications needed when doing Plastic Parts Manufacturing?

S

Spacecowboyscrew

#1
Hi,

Our company(ISO 13485 certified) will be venturing into plastic parts supplier thing. We will do the following items:

1. Plastic parts machining.
2. Plastic parts moulding.
3. Plastic parts sheet fabrications.
4. Wire harness.
5. Inspections for all the above items.
6. Test for all the above items.

What certifications do we need to get to go along with ISO 13485 ?
a. For Americas?
b. For Europe?


Any comment much appreciated.
 
Elsmar Forum Sponsor
T

temujin

#2
What certifications do we need to get to go along with ISO 13485 ?
a. For Americas?
b. For Europe?
None.
A 13485 certificate is valid on its own.

However, are you manufacturing or planning to manufacture medical devices, or parts for medical devices?

Why do you want to be 13485 registered?

regards
t.
 

Ajit Basrur

Staff member
Admin
#3
Hi,

Our company(ISO 13485 certified) will be venturing into plastic parts supplier thing. We will do the following items:

1. Plastic parts machining.
2. Plastic parts moulding.
3. Plastic parts sheet fabrications.
4. Wire harness.
5. Inspections for all the above items.
6. Test for all the above items.

What certifications do we need to get to go along with ISO 13485 ?
a. For Americas?
b. For Europe?

Any comment much appreciated.
Agree with Temujin.

On an additional note, will you be just molding parts or molding parts and assembling for finished medical device ?

I would like recommend you to have a look at 21 CFR Part 820 being the quality management system for medical devices per US FDA.
 
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