Medical Electronics Symposium Conference Proceedings


Author: Jim Schultz
Company: Benchmark Electronics
Date Published: 5/19/2004   Conference: Medical Electronics Symposium

Abstract: Among the challenges faced by EMS providers that manufacture medical electronics for their OEM customers is the issue of component and assembly traceability. The Food and Drug Administration requires manufacturers to identify components and assemblies during all stages of receipt, production, and distribution. This is done in order to minimize the impact of any product recall that may be necessary if a defect in a component or assembly is discovered.

In order to maintain certified records that the product manufactured meets the design requirements for the finished assembly, the manufacturer must keep Device History Records (DHR’s) and Device Manufacturing Records (DMR’s) for every finished assembly shipped. During an FDA audit, these records are compared to assure that the appropriate components were used. An appropriate component or assembly would be one that has met the design requirements of the finished product and has passed all incoming inspection criteria. An FDA audit would likely include comparison of the Device History Records against the incoming and in-process acceptance records for the components used to assure only acceptable components were used in each stage of the manufacturing process.

This paper will detail how to establish component, sub-assembly, and finished device traceability, and how a database of incoming inspection, manufacturing, and test data can be used to contain product once traceability is established. Incoming inspection and supplier control issues will also be explored in this paper as they relate to traceability. The paper will conclude with an exercise in containment using traceability tools.

Key words: medical, traceability, FDA, containment.

Members download articles for free:

Not a member yet?

What else do you get when you join SMTA? Read about all of the benefits that go along with membership.

Notice: Sharing of articles is restricted to just your immediate work group. Downloaded papers should not be stored on an external network or shared on the internet.


SMTA Headquarters
6600 City West Parkway, Suite 300
Eden Prairie, MN 55344 USA

Phone +1 952.920.7682
Fax +1 952.926.1819