Tech Hub > On Demand, Project and Requirements Management
3 minute read
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.
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.
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.
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.
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.
Download all three webinar parts using the form on the right hand side. You will receive instant access to the webinars via email after submitting your entry.
For any further information and help with Polarion ALM, please get in touch with us.
Talk with our experts and explore our customer portal to manage and track your questions, as well as explore our product advice and support guides.
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