This three-part webinar series will introduce “Intelligent Design Control” of Mechatronic Medical Devices in Polarion ALM. Each part will take a detailed 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.
Part 1 of the series focuses on sourcing and design inputs and establishing critical traceability across all design artifacts. Part 2 of the series will show how to envelop the risk management process and incorporates it directly into the traceability of the intelligent design control. And Part 3 of the series will show 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.
Presented by Larry Sampson, Sr. Director in Siemens PLM Software's Medical Device Industries group with over 20 years medical device experience. In this webinar, Larry will take you through the pitfalls of procedural design control and share with you how using Polarion can enable you to do intelligent design control.
Polarion is a portable framework capable of mirroring any design methodology and workflow or process, and can be rapidly implemented in an incremental manner so that groups are brought into the process while fostering adoption. The results of which are a collaborative approach that will ensure that your development, quality/testing efforts are more efficient and cohesive, and bottom-line will reduce your cycles and time to market.
Join us to discover the benefits of a software platform that will provide you a multidimensional, traceability solution for complex development environments in this one hour webinar.
Please register to get immediate access to this on-demand webinar.