Anyone have experience with UL as ISO 13485/CMDCAS and MDD registrar

[DannyK]

In Reply to Parent Post by Elizabeth Rafferty

I have reviewed this, and for a company my size, it states five days for Stage 1 + Stage 2. Not sure what the stages are...........

For a re-assessment, you take the number of initial days and multiply by 2/3.
The auditor/registrar will then add time based on complexity, number of standards, etc...
In your case, the 4 days sound reasonable since you have not excluded design and you have additional requirements to review (MDD & CMDCAS).

[Elizabeth Rafferty]

Thank you, Andy. I did read MD9, MD5 and ISO 17021. I sent a letter to my registrar asking to clarify their thinking on audit time as it didn't mesh with the documents I read. I'm waiting for their response. If they can adequately justify their audit time, I will likely stay with them. The rep for UL is supposed to confirm that they are using MD9 (I think they are not).

I really appreciate all the help you have given me. Hopefully I can pay it forward in the future.