Adding new supplier/ Medical device design change

[adztesla]

Hi all,


1. I am adding a new supplier to a raw material we use to make our product (catheter), we assess our change through a change notice, however, since we are a start-up, it's not a clear process, and therefore, could somebody let me know the guidelines and assessment I have to review while adding a new supplier. Also, when adding a new supplier, will it be a design change? The supplier from whom we are going to source this material is already on the ASL list.

2. Post-market projects - What is considered a design change in medical devices?

Thanks,

 

[William55401]

These are good questions but more information is needed to parse out an accurate answer. I think there may be a steep learning curve a head. I encourage you to search the forum on design chang. the bottom line here is, have you adequately verified, and or validated the supplier change. Don’t get caught up in the supplier. Focus on the material they are providing. Are they processing it or are they just a middle person? I know others more capable will jump in, but please share more detail on the nature of the change. The short answer on design changes is that your verification activities must be aligned to the risk of the change. I got a run. Have fun enjoy the ride.

 

[Ed Panek]

If the new supplier is able to meet your design spec for the component it may not require any design changes. Perform a risk assessment and go from there.

Depending on which regulations you are under the FDA/EU has specific guidance on what is/is not a major change in a device. You can google those documents.

Aside from assuring the devices being marketed are safe and effective, regulators need to stay abreast of "The latest performance" of medical devices so they are sure their stakeholders are getting the best possible care.