Article | August 1, 2017

OEMs: Do You Trust Your Medical Device Supplier's Quality?

Source: Flexan/FMI, Inc.

By Leo Gelera

OEMs: Do You Trust Your Medical Device Supplier’s Quality?

As an OEM, it is your responsibility to ensure the parts supplied to you are compliant with ISO regulations. That is no easy task. Ideally, your supplier’s quality systems are strong enough to identify risks, prevent defects, and to catch defects quickly if they do occur. This requires a robust quality management system. When it comes to evaluating the quality systems of your medical device supplier, where do you begin?