Vendor Qualification Summary

1 articles

Qualifying Your Vendor

By Ken Herold Every medical device manufacturer marketing their device in the US must comply with regulations such as 21 CFR 820.50 Subpart E Purchasing Controls. This applies to all outside components they wish to incorporate into their device, including software. In part, this requires the manufacturer to: “(1) Evaluate and select potential suppliers, contractors, and consultants on the basis…