Narratize gives medical device and diagnostics teams a Product Knowledge Hub engineered for FDA design controls, EU MDR compliance, and the reality that every decision, change, and justification must be captured — defensibly — across a multi-year development cycle.
Medical device R&D sits at the intersection of FDA design controls, EU MDR compliance, multi-year development cycles, and the knowledge that patient safety rides on every decision. The challenges aren't generic innovation problems — they're specific to the industry, and they compound.
21 CFR 820.30 and ISO 13485 don't just demand that you build safe devices — they demand that you prove how you built them. Every design input, output, change, and review has to be defensible years later, to reviewers who weren't in the room when the decisions were made.
Device programs span three, five, sometimes ten years from concept to clearance. Across that timeline, engineers rotate, priorities shift, and institutional memory erodes. The team that submits the 510(k) rarely matches the team that wrote the user needs.
Mechanical engineers, firmware leads, regulatory veterans — the people who understand your legacy platforms hold decades of tacit knowledge about why decisions were made. When they leave, that reasoning doesn't come with them unless someone has captured it.
Platform strategies only work when each generation carries forward the reasoning, trade-offs, and learnings from the last. Without a structured way to preserve that context, each new device ends up re-litigating decisions that were already made three generations ago.
Narratize doesn't adapt a generic innovation platform to medical devices. The workflows, templates, and agents are engineered for how regulated device teams actually produce and defend their work.
Your Design History File builds itself as your team works. Design inputs link to user needs. Outputs link to inputs. Verification activities link to outputs. Every decision carries its reasoning and source. When audit or submission time arrives, the DHF is already complete — not a frantic assembly job the month before.
510(k), PMA, De Novo, EU MDR technical files — each one built from the same structured hub knowledge your team has been capturing all along. Your regulatory affairs team stops chasing documentation across SharePoint, email, and engineers' drives. They start assembling submissions from a single, source-traced foundation.
The hub maintains live traceability across user needs, design inputs, design outputs, verification, validation, and transfer. When a requirement changes, every impacted artifact is visible. When an auditor asks for the chain of evidence behind a single design decision, your team can produce it in minutes.
Your Risk Management File — hazards, harms, control measures, residual risk assessments — lives inside the same hub as the rest of your product knowledge. When a design change is proposed, the relevant risk analyses surface automatically. ISO 14971 compliance stops being a parallel track and becomes part of the design record itself.
From R&D and design engineering to regulatory affairs, quality, clinical, and commercial — every function that touches a device program contributes to and draws from the same Product Knowledge Hub. The handoffs stop being lossy.
Engineers document decisions as they make them. The trade-offs, the rejected alternatives, and the logic stay with the design — not in someone's head or a Slack thread.
510(k) and PMA submissions built from the hub's structured knowledge. Every claim in the submission traces back to the design record. Reviewers see the chain of evidence immediately.
Design reviews, change controls, CAPA documentation, and audit responses all run on the same hub — so QMS documentation stays synchronized with what's actually happening in development.
Clinical investigation plans, study reports, and post-market surveillance data link back to the design controls they support. When a clinical finding affects a design input, the connection surfaces.
Process validation, DMR assembly, and transfer documentation inherit the design history directly — so manufacturing starts with the full context of why the device was designed the way it was.
Every marketing claim, clinician-facing material, and sales enablement asset rests on verified design and clinical evidence. The distance between R&D truth and go-to-market message shrinks to nothing.
Narratize's medical device customers span diagnostics platforms, surgical devices, implantables, wearables, and digital therapeutics — all operating under the same reality: the rigor cannot slip, and the pace cannot either.
R&D and regulatory teams at established device manufacturers use Narratize to carry institutional knowledge across long development cycles, executive transitions, and platform generations — so the tenth device benefits from lessons learned across the first nine.
Platforms with multiple cleared assays use Narratize to share core technology knowledge across assay teams — chemistry, software, instrumentation — while maintaining the distinct regulatory records each assay requires.
Device innovators moving from their first 510(k) toward a broader platform use Narratize to institutionalize what worked in their first clearance — so the second, third, and fourth clearance run on the accumulated intelligence, not a blank slate.
SaMD teams use Narratize to reconcile the pace of software development with the rigor of medical device regulation — keeping design controls, risk management, and regulatory documentation synchronized with continuously evolving product.
Measured across Narratize customers, cycle-time compression without shortcuts on evidence, rigor, or defensibility.
Time freed from documentation assembly, evidence chasing, and context reconstruction — returned to engineering, regulatory, and clinical work.
Documentation produced with Narratize's structured workflows scores materially higher on completeness and defensibility than traditional approaches.
30 minutes. Bring a device program in flight — or one you're scoping. We'll walk you through what a Design History File, submission package, or risk management record looks like when it's been building itself as your team works.
Schedule a Demo →