On-demand Webinar:

Medical Device Intelligent Design Control - Part 2 of 3


This webinar series is an in-depth overview of “Intelligent Design Control” in Mechatronic Medical Devices utilizing Polarion ALM. Each webinar will take a different look at key features that streamline and automate the process, and maintain critical traceability throughout with building an electronic Design History File (eDHF) including:

  • Incorporating standards and regulations sources into Design Control
  • Risk analysis and mitigation – ISO-14971 “harms down” inclusion into Design Control
  • Design verification & validation protocols, execution, and report evidence.
The series will show how to optimize and digitalize your Risk Management process and incorporate it directly into the traceability features of Intelligent Design Control. Moving forward, we will demonstrate how testing features in Polarion answer the multiple demands of verification and validation throughout a complex design control process, with necessary evidence for the eDHF.

Polarion is a portable framework capable of mirroring any design methodology and workflow or process. It can be rapidly implemented in an incremental manner so groups are brought into the process while fostering adoption. The results of which are a collaborative approach that will ensure your development, quality/testing efforts are more efficient and cohesive. Bottom-line a unified solution for software development will reduce your cycles and time to market.

Join us for this complimentary 40-60 minute webinar to discover the benefits of a software platform that will provide you a multidimensional, traceability solution for complex development environments.


david_merrill.pngDavid Merrill
David has traveled the globe training customers to utilize Application Lifecycle Management (ALM) software since 2004. He has also developed and implemented software and solutions in Cybersecurity and ITIL configuration management for such organizations as Symantec, the US Air Force, Office of Naval Intelligence, and the TJX Companies. David is a graduate of Cornell University with a degree in Applied and Engineering Physics.


Please register to get immediate access to this on-demand webinar.