From speculation to predictability
Enhanced patient safety isn’t just about strong testing - it comes from robust interfaces and risk work that goes beyond qualitative judgement. RD8 brings quantitative methods and traceability into DFMEA, turning documentation into real design control.
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In regulated processes, DFMEA is often qualitative and documentation-heavy. That creates dependency on individual risk experts and weakens the link to specifications. The result: limited impact, missed interactions, and unclear traceability.
RD8’s quantitative approach to DFMEA and interface risk
Predictability at the interface level
We identify and quantify unwanted mechanical interactions with a bottom-up process. Rule-based checklists ensure no negative effects are overlooked, and identified risks are aggregated at system level and linked directly to requirement specifications.
Couplings, dependencies, and traceability
Through a top-down architecture process, we establish clear interface specifications and maintain traceability across requirements, drawings, and mitigations. This creates a direct link between DFMEA work and real product design.
Dimensioning for capability
By combining tolerance allocation methods or real capability data, we link part specifications to rationales and control strategies. This enables data-driven DPMO forecasts and makes risk control both verifiable and efficient.
Ready to get more out of your DFMEA work?
RD8 helps device teams turn DFMEA from a qualitative documentation exercise into a quantitative design control process - faster, clearer, and more predictable. Let’s explore if this approach is relevant to your project.
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