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:
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.
An eDHF is the digital equivalent of the paper-based Design History File required by FDA 21 CFR Part 820. Polarion builds the eDHF as a natural by-product of your design control process — every requirement, risk analysis, verification protocol, and validation result is automatically linked and version-controlled, eliminating manual document assembly.
Polarion integrates risk analysis directly into the design control traceability chain using a 'harms down' approach. Hazards, harms, and risk mitigations are linked to design inputs and outputs — so risk decisions are traceable from initial hazard identification through mitigation verification, all within the same platform used for design control.
Yes. Polarion is a portable framework capable of mirroring any design methodology across mechanical, electrical, and software domains. It manages IEC 62304 software lifecycle alongside hardware design controls, providing unified traceability and a single source of truth for cross-functional mechatronic teams.