1. Hello and Welcome to The Quality Forum Online...Continuing in the spirit of People Helping People !
    Dismiss Notice
Dismiss Notice
You must be a registered member in order to post messages and view/download attached files in this forum.
Click here to register.

Can I Exclude These 13485 requirements?

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Nikki, Jan 28, 2016.

  1. Nikki

    Nikki Well-Known Member

    Joined:
    Jul 31, 2015
    Messages:
    254
    Likes Received:
    137
    Trophy Points:
    42
    Location:
    Maine
    Hello QF Experts,

    I have some questions regarding some of the 13485 requirements and if I can exclude them or not...

    Background: My company compounds plastics with specific colorants and / or radiopaque fillers per customer specification. The plastic is compounded into pellet form and sold to medical customers. The customers make medical devices from this plastic.

    We do not make medical devices. Just the plastic pellets. With that said, do the following requirements apply to us?

    7.5.1.2 - Control of Production & Service Provision
    7.5.1.2.1 - Cleanliness of product and contamination control
    * We do not conduct any sterilization or cleaning of the product after it has been compounded.

    7.5.1.2.2 Installation Activities
    *We don't install anything - it's plastic pellets

    7.5.1.2.3 Servicing Activities
    *We do not provide servicing - again its plastic pellets

    7.5.1.3 Particular requirements for sterile medical devices
    *Plastic pellets - not a medical device

    7.5.2.2 Validation of Sterilization Process
    *We do not conduct sterilization

    7.5.3.2.2 Particular requirements for active implantable medical devices - Traceability.
    States that we need to record our environmental conditions.
    *Does this apply to our pellets - as it is not a medical device?

    Sorry to throw all this out there..

    Thoughts?

    Thanks in advance!
     
  2. Ronen E

    Ronen E Well-Known Member

    Joined:
    Jul 31, 2015
    Messages:
    133
    Likes Received:
    70
    Trophy Points:
    27
    7.5.1.2.1 - Probably applies due to (c). I'm guessing that your pellets might sometimes be used in your clients' clean-room facilities.

    7.5.3.2.2 - I would say it applies in cases where your pellets go into making implants. Environmental conditions, though, need only be documented for the above if they could adversely affect the pellets meeting their specifications (I'd venture to say they sometimes would).

    All the rest - N/A.
     
    Nikki likes this.

Share This Page