Skip to the content


Register for the Free webinar on Wednesday 9th October, at 2 pm EDT.

How to Improve Design Control Workflow in Medical Device Manufacturing

Design Control is a procedure used to control the design of medical device development with the purpose of ensuring that specified design requirements are met. Along with Risk Management, the Design Control discipline is where a medical device’ journey starts.

The typical industry practice is to design and print: create the design and then print to paper and store that document in a binder. Very often, the documents are printed, scanned and stored both electronically in file folder structures as well as in physical binders. The problem with this manual process is that it is very labor-intensive and time-consuming. But more importantly, it is also error-prone. Even if the product meets its intended use, having records that are incomplete or stored in the wrong version puts the medical device product at risk.

In this Free webinar, you will learn more about how to establish a comprehensive Design Control workflow which minimizes these gaps and targets the challenges that face medical device companies every single day.

Participants will learn

  • How to improve efficiency in design control
  • How to secure and improve traceability
  • How to improve visibility and processes
  • How to secure a complete audit trail in one system

White paper - Business of Engineering and Medical Device

Interested in the Business of Engineering in medical device manufacturing?

Read more about how integrating MBSE and PLM can enable medical device organizations to excel at verifying the behavior and design of their systems.