Here’s the truth. If an FDA inspector comes to your facility, he or she will want to see how you have configured your Corrective and Preventive Action (CAPA) program. Bet on it.

Released By AssurX Inc.

AssurX, Inc., has just released a white paper for the medical device industry titled: “FDA Importer Guidance For Devices: Guidance on Good Importer Practices signals 2009 will be a year of a more focused, active agency”. To get a complimentary copy, please go to: http://www.assurx.com/FDAImporterGuidanceWhitePaper.html

Released By AssurX Inc.

AssurX, Inc., has just released an eBook outlining the benefits of implementing eMDR (Electronic Medical Device Reporting). This complimentary eBook goes into detail about how eMDR works, what the FDA says about eMDR, and the benefits of adopting this technology through developing an effective strategy. It is available by request only by visiting http://www.assurx.com/emdrebook.html

Released By AssurX Inc.

AssurX, Inc, a leader in quality management and regulatory compliance systems, has released its Supplier Quality Management solution. The AssurX SQM™ is a 100% Web-based solution that provides best practices process for companies managing and tracking suppliers and contract manufacturers globally. Available as either OnPremise or OnDemand (SaaS), AssurX SQM enables total transparency and visibility […]

Released By AssurX Inc.

(MORGAN HILL, CA) AssurX, Inc, the leader in enterprise quality management and regulatory compliance solutions, today announced the release of its new CATSWeb PreConfigured Quality Management and Regulatory Compliance Solutions offered as Software-as-a-Service (SaaS) software delivery model offering organizations with an alternative easy-to-use, secure, and reliable enterprise quality solution that is accessed over the Internet […]

Released By AssurX Inc.

CATSWeb Complaints Management & Regulatory Reporting system provides a best practices process for managing the entire event lifecycle: event intake through investigation, root cause analysis and reporting to regulatory agencies. Comes with built-in dashboards and metrics that are user configurable.

Released By AssurX Inc.