I am helping a friend developing internal audit checklist, for a device use for circumcision. It is a disposable one-time "clamping" device.

Perhaps some input with the checklist questions are really helpful.

Thank you

Lim.

I am helping a friend developing internal audit checklist, for a device use for circumcision. It is a disposable one-time "clamping" device.

Perhaps some input with the checklist questions are really helpful.

Thank you

Lim.

Lim,

Your previous posts were about performing internal audits in Construction and Electrical Services organizations. This post involves a medical device. I am just curious: Have you and/or your friend had any involvement with medical devices?

Are you asking for a process audit checklist or a product audit/inspection checklist?

Providing us with some more specifics would help.

Stijloor.

The FDA

In the year 2000 the FDA issued a warning about circumcision clamps, which it said can cause laceration, hemorrhage, penile amputation, and urethral damage.

Stijloor,

Lim is a very helpful person. He like to help many frens -be in medical products or construction / services organizations....:bigwave:

Circumcision Clamps are Class II medical devices and would require the same quality management systems as per 21 CFR Part 820. You could refer the various Internal Audit checklists that we have here in this Cove.

Additionally, take a look at 21 CFR Part 884.4530 (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=884.4530) as it falls into this category for Obstetric-gynecologic specialized manual instruments.

Hello everyone.

I wrote in the forum regarding this topic before I left for overseas.
I was looking for process audit actually. I had this IRCA training six months ago, and most of us came from different industries. So when we had any doubt about our related system, we would contact each other.
and elsmar has been very helpful too.