Medical · Compliance
About this session
This webinar series is an in-depth overview of "Intelligent Design Control" in Mechatronic Medical Devices utilising Polarion ALM. Each webinar takes a different look at key features that streamline and automate the process, and maintain critical traceability throughout — 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 shows how to optimise and digitise your Risk Management process and incorporate it directly into the traceability of the Intelligent Design Control. We 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 are a collaborative approach that will ensure your development, quality/testing efforts are more efficient and cohesive. A unified solution for software development will reduce your cycles and time to market.