Medical Device Visuals (FDA 510(k), Marketing)

Visuals that accelerate 510(k) and launch

We create device visuals that regulatory reviewers can parse quickly and that your commercial team can use immediately. One visual language across Regulatory Affairs, Clinical, and Marketing means fewer MLR rounds, faster internal alignment, and clearer understanding of how the device works and is used.

When to bring us in (common triggers)

  • You’re preparing a 510(k) or De Novo submission.
  • Your IFU needs to illustrate use steps and user tasks.
  • You’re planning a launch and need consistent visuals for web, sales, and training.

What you get

For Regulatory

  • Device overview diagrams: components, interfaces, accessories, patient contact.
  • Principle-of-operation sequences: concise step-by-step visuals that show energy/flow/mechanics and safeguards.
  • Hazard–control overlays: tie risks to mitigations at the point of use.
  • Comparison visuals (when applicable): predicate vs. new device at the level of function and technology.
  • Traceability pack: a “visual ↔ source” map linking each label/claim/step to the exact source (report, page, figure).

For IFU & Human Factors

  • Task flows for intended users and environments.
  • Line-art procedures for setup, insertion, operation, cleaning, disposal.
  • Use-error callouts with warnings/cautions where they matter in the sequence.
  • Alt-text/transcripts to support accessibility and reviews.

For Marketing & Launch

  • Cutaways, clean MOA schematics, and explainer animations aligned to the same facts as the regulatory set.
  • “Fair balance” panels integrated into slides and web blocks so review cycles go smoother.
  • Launch kit: hero visuals, short explainer (30–60s), sales slides, and stills for web/PR.

Why hire California Technical Media for this work?

  • Single visual language across teams → fewer contradictory edits and fewer MLR cycles.
  • Reviewer-friendly sequencing → shows “what, when, why” without narrative bloat.
  • Evidence-anchored → every element is traceable to your DHF/usability file/test data.
  • Dual-use outputs → regulatory and commercial versions built from the same approved core.

Process (fast, review-friendly)

  1. Data intake
    We ingest source material (design/bench/clinical summaries, draft IFU, risk controls, CAD). We align on intended use and claims boundaries.
  2. Storyboard by regulatory logic
    We structure visuals to follow how a reviewer reads: device description → MOA → user tasks → risks/controls → comparisons (if relevant).
  3. RA/SME alignment
    Short working sessions to confirm assumptions, terminology, and what must/ must not be shown. We flag anything that requires substantiation.
  4. Two synchronized builds
    • Regulatory cut: neutral tone, no marketing claims, emphasis on clarity and controls.
    • Marketing cut: same core facts, benefit statements with balanced safety info.
  5. Final package & handoff
    Editable masters + locked PDFs/MP4s, the visual ↔ source trace map, review notes, and alt-text/transcripts. We keep a changelog for future submissions.

Compliance, risk, and review control

  • Assumption accuracy: if requested, every assumption is flagged, confirmed with an SME, and documented in the trace map.
  • Human factors: visuals mirror actual user tasks and essential performance; error-prone steps are explicitly marked.
  • “Fair balance”: any benefit statement pairs with material risks/limitations in the same frame/slide.
  • Claims discipline: every claim-like phrase gets a substantiation link (bench test, clinical data, labeling).
  • Version hygiene: regulatory vs. marketing versions are tracked to avoid cross-contamination of claims.

Deliverables & formats

  • Still graphics (JPG/SVG/PDF/PNG) for submissions, IFU, labels, packaging.
  • Animations (MP4 30–120s) for MOA and use steps.
  • Slide modules (PowerPoint) with review notes and balanced claims blocks.
  • CAD-based renders or schematic line-art, depending on confidentiality and review needs.

Engagement options

  • Core 510(k) Visual Set: device overview, MOA sequence, IFU task flow, risk-control overlays, trace map.
  • Launch Add-On: explainer animation, hero stills, sales slides built from the approved core.
  • IFU Deep-Dive: expanded procedures, cleaning/sterilization, troubleshooting trees.
  • Custom: let us know what you need.

What we need to start (send these if available)

  • Intended Use / Indications for Use (draft is fine).
  • Device description and any CAD or reference geometry (we can work with redacted exports).
  • Key risks and controls you want reflected (a short risk summary works).
  • Draft IFU sections or known user tasks/environments.
  • Evidence summaries for any benefit statements you plan to keep.
  • Brand basics (logo, type, color) for commercial outputs.

Mini-FAQ

Can you work without CAD?
Yes. We can build schematic line-art or clean proxies and swap in real geometry later or we can model anything from photographs, sketches or other source materials.

Our IFU and claims are still evolving. Is that a problem?
We design to the strictest version first, then relax for marketing if/when approved. The revision process can adjust to your process, however. You can drive these decisions.  

How do you handle confidentiality?
We work under NDA, keep compartmentalized file access, and can avoid sensitive internals by using schematic layers when required.

Next step

Email Hello@CaliforniaTechnicalMedia.com or Schedule a Call with one of our co-founders. 

We’ll confirm the terms, scope, onboarding considerations and create a project roadmap.