Medical Device Intelligent Design Control
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 digitze your Risk Management process and incorporate it directly into the traceability of the 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 DHF. 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.
30+ years of industry experience.