Physio-Control: Supply Changes Key to Lifting Consent Decree

Physio-Control, a division of Medtronic, made major changes in how it does business with suppliers as a key part of its efforts to satisfy a two-year consent decree.

For example, the company trained its critical suppliers on validation and statistical methods using Global Harmonization Task Force guidance as a basis, Physio-Control President Brian Webster said. It also instituted a robust supplier process monitoring program.

Physio-Control’s contractual arrangements with suppliers enabled it to extend quality system improvements to its supplier network, he said.
The GMP Letter