Medical Device Quality Management System – ISO 13485

A medical device without proper documentation is an accident (or audit) waiting to happen. An automated document control system can not only organize your documents so that you can find them when you need them; when you change a document tied to a particular product, they can also use automated workflows to make corresponding updates to any related documents.

A QMS keeps track of everyone associated with a product — from the vendors who supply the raw materials to the folks who check quality on the plant floor. If there’s a nonconformance, a workflow automation can notify everyone involved that there’s all problem to solve and mitigate. It can get everyone in corrective action mode without wasting valuable time.

Closely integrating customer complaint management with other QMS functions enables identification and analysis of suspected cause and process failures, informing the need for containment action.

As more and more medical devices are IoT-enabled, a QMS can monitor the information they generate and initiate proactive responses when there’s a nonconformance.

If a company requires their suppliers to meet certain criteria, the QMS can provide the platform for entering and updating information about the vendor’s own quality management.

• Foster better communication and visibility with suppliers
• Increases visibility on both sides and track items that need to be addressed
• Improve responsiveness of suppliers, while also streamlining collaboration at every phase of the process