It seems like I'm starting out asking more questions then answering them, but I'm trying to weed my way through the MDD and see how I can tell whether or not my QMS is MDD compliant. I'm working toward ISO 13485:2003 certification, but I know that's not necessarily the same though in some ways it should get me closer. I've got the latest revision of the MDD from the European Commission website as well as the latest technical revision, and I'm weeding my way through it, but is there anywhere to go that has an easy comparison to ISO or FDA regulations? Thanks in advance for any help.
12stones,
I know of no comparison of MDD with ISO 13485; they are different beasts.
Make sure that your management system includes a process (with a procedure documented to the extent necessary for effective planning, operation and control) for:
Deploying regulatory requirements to the QMS.
This process would update the system in anticipation of regulatory changes, evaluate compliance and initiate any necessary preventive action or corrective action to assure compliance.
This process would be audited like any other for its effectiveness from time to time.
Meanwhile, you could evaluate documentary compliance by use of a matrix of the MDD requirements against the procedures in your system to see if you have the controls in your QMS necessary to assure MDD compliance.
John
