Differences in Manufacturing of Class I, II and III Medical Devices

[Ajit Basrur]

Hi all,

Just want to put this question to gather all possible responses -

"If an organization that is currently manufacturing Class I medical devices intends to manufacture Class II and Class III devices, what upgradations, be it quality systems or manufacturing environment or any other, would you suggest ?"

[sshankle]

Here's a couple off the top of my head...

1. You may need to look at your Design Controls processes to make sure they are robust, since these are no required for most US Class 1 devices.

2. Change control. While a requirement for Class 1's, this becomes more involved for Class 2's and especially 3's. The Change Control processes must include a review for when additional regulatory fillings and amendments are required. Class 3 devices are more strictly regulated in this regard.

Hope that helps.

Scott

[Ajit Basrur]

Thanks Scott.

Welcom to the Cove I note that though you have been registered in 2006, this is your first post.

Hope to have your active participation.

[chris1price]

This is interesting, technically the Quality Systems should all be compliant to the QSR. However in practice manufacturers of class III devices will need to have much higher levels of document and change control and as stated, Design Controls may not be needed for class I. Similarly, I would expect manufacturers of Class III devices to have more Regulatory Affairs Experts on hand.

Perhaps the biggest difference, is that a Class III manufactuers will receive FDA inspections on a regular basis, whereas someone who just makes Class I devices will be inspected much less frequently.

[Ajit Basrur]

Thanks Chris.

Any other differences ?

[rick tompkins]

good morning all---

one of my company's customers is embarking on a supplier Class III validation Project for implantable components we produce for them (and others).
It's a long and detailed documentation process.
Anyone doing this now?

Rick, Illinois

[treesei]

Theoretically, the same quality system applies no matter what class the facility is made. In reality, more control will be placed when the facility upgrades from class I up. I would go back to the risk management requirement. I probably would do FMEA for the products and processes, then do FMEA gap analysis, and then implement necessary measures to minimize the risk. Since FMEA, like HACCP, is process/product specific, the differences, and the actions taken to fill the gap, could be process/product specific too, case by case.

[Ajit Basrur]

Agree with you, treesei.

The entire ISO 14971 requirements to include the Risk management will ahve to be adopted.