Part 1: Setting Up a New Device
Set up a new medical device in Obodux and lay the foundations for an ISO 14971 and MDR-compliant risk management file.
Step-by-step training videos and walkthroughs to help your team get the most out of Obodux, from setting up a device to exporting your technical file.
Set up your first device and bring your existing technical file into Obodux.
Set up a new medical device in Obodux and lay the foundations for an ISO 14971 and MDR-compliant risk management file.
Populate the Device Description and start building your technical file in line with EU MDR and ISO 14971.
Import your existing technical file in any format (PDF, Word, Excel, CSV or ZIP) and watch Obodux sort it into structured modules.
Build an ISO 14971 risk management file, from plan to report.
Create a complete Risk Management Plan aligned with ISO 14971:2019, EU MDR, UK MDR and FDA requirements.
Work through the Initial Hazard Review, the next step in building your ISO 14971 risk management file.
See how simple it is to complete the Risk Analysis Matrix in Obodux.
Complete the Individual Benefit-Risk Analysis and Overall Residual Risk sections, generated from your risk analysis.
Export your documentation and get expert help when you need it.
Generate, preview and submit documentation for your MDR technical file pathway.
Request help from a linked or external consultant, message them in the platform and use the built-in guidance.