Clinical Trial and ISO13485 Requirements

Kelly84kl

Registered
We are yet to be certified to ISO13485 and the current scope of the audit (due in October) is product design and development, we plan to go to clinical trails in Q1 of 2025. Do we need to include 'manufacture' in the scope of our ISO audit for the devices we will make for the trials?

Also, to confirm, we will need to document within the QMS all the procedures for making the devices?
 

Chrisx

Quite Involved in Discussions
I would not recommend manufacturing human-use product with uncontrolled procedures, regardless of whether you are seeking certification. The regulatory requirements will vary depending upon the location of the trial.
 

QuinnM

Involved In Discussions
If you are receiving a audit for 13485, then you will either need to have procedures in place, or document areas of the standard which are excluded or not applicable to your organization. If your organization is the manufacturer, then you will need applicable procedures.
 

R Walsh

Registered
If you are receiving a audit for 13485, then you will either need to have procedures in place, or document areas of the standard which are excluded or not applicable to your organization. If your organization is the manufacturer, then you will need applicable procedures.
This. A big issue for my company is that we buy sub components and assemble them into a final product. Since we purchase sub components we had to enact procedures to verify and validate the safety and performance of those purchased components. This was also because the supplier would not preform the quality control themselves.

If you are the sole manufacturer (no buying sub components) then yes. You will need to document within the qms all of the procedures and work instructions related to the production.
 

yodon

Leader
Super Moderator
Just to twist things up a bit, 13485 certification probably has nothing to do with the clinical trials. As @Chrisx notes, though, you do want to make the devices in a controlled manner with sufficient provenance. Trial requirements should be driven by the IRB (or equivalent). I don't believe I've heard of anyone having to have a 13485 cert before going into a trial.
 
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