Consent Decree

The Consent Decree will be in effect for a minimum of five years. We anticipate that resolving the Consent Decree related issues will take some time, as an effort to improve our compliance documentation, ensure a consistently compliant quality system, and engage in extensive third-party audits is an intensive and exacting process.

 

The specifics of timing and sequence of our defibrillator manufacturing and shipping returning online are subject to third-party input and validation, and we will address those questions when we have a clearer picture of the roadmap currently in development.