From Prototype to FDA Approval - Accelerate Your Medical Device Documentation

Trusted by medical device companies for breakthrough device visualization, 510(k) documentation, and technical excellence for 50+ years

Why Medical Device Innovators Choose JANA Life Sciences

    • VP.S ENCORE® Heart Transport Device (FDA Breakthrough Designation)

    • 8-business-day 3D modeling and visualization turnaround

    • 510(k) and PMA documentation expertise

    • CAD experts, graphic artists, and engineers

    • Compelling videos for training and marketing

    • Investor presentation-ready visualizations

    • 250-page Instructions for Use (14-week delivery)

    • ISO 13485:2016 certified medical device quality systems

    • Complex system documentation and training materials

Complete Medical Device Documentation Solutions

  • Service Categories

    - Regulatory Documentation: 510(k) submissions, PMA applications, FDA Breakthrough Device support

    - 3D Modeling & Visualization: Device modeling, animation, rendering for presentations and training

    - Technical Documentation: IFUs, user manuals, service procedures, maintenance guides

    - System Validation: Medical device software validation, risk management documentation

    - Training Programs: Device operation training, service technician documentation

  • Case Study Spotlight

    Featured Success Story: "VP.S ENCORE® Heart Transport Device Success"

    - Challenge: FDA Breakthrough Device requiring rapid visualization for investor presentations

    - Solution: Complete 3D modeling, animation, and documentation in 8 business days

    - Results: FDA Breakthrough Device Designation achieved, successful Series A funding

    - Quote: "JANA's rapid 3D modeling helped us secure FDA Breakthrough status and critical funding. Their technical expertise was invaluable." - Rafael J. Veraza, PhD, MPH, VPS CEO

  • Technical Capabilities Showcase

    Advanced Technical Capabilities for Medical Device Innovation

    - 3D Modeling Excellence: CAD, animation, simulation, rendering

    - Multimedia Production: Video production, still photography, mixed-media training

    - Complex Device Documentation: Cardiac monitoring, robotic radiotherapy, diagnostic equipment

    - Rapid Prototyping Support: 8-day turnaround proven capability

Strategic Support for High-Impact MedTech Innovation

  • Downloadable Resources

    - "FDA Breakthrough Device Documentation Checklist" (Based on VP.S ENCORE® success)

    - "Medical Device 3D Modeling Project Estimator" (Timeline and cost planning tool)

    - "510(k) Submission Documentation Template" (Complete preparation guide)

  • Radiography & Medical Imaging Specialty

    Specialized Expertise in Medical Imaging Technology

    - RSNA, ASTRO, NAPT Conference Presence: Regular exhibitor and industry participant

    - Complex Imaging Documentation: Robotic radiotherapy, proton therapy systems

    - Training Program Development: 6-week multimedia programs with AR preparation

    - Industry Relationships: Deep connections in radiography and imaging sectors

  • Competitive Differentiation

    Beyond CAD Services - Complete Medical Device Partnership

    - vs. Design Agencies: Regulatory documentation expertise plus visualization

    - vs. Technical Writers: Engineering and 3D modeling capabilities

    - vs. Large Consulting: 8-day rapid turnaround with personal service

    - Family-Owned Advantage: Direct access to decision makers and technical experts

  • MedTech Client Testimonials

    - VP.S ENCORE® device success story

    - Robotic radiotherapy training program

    - Protein analysis machine documentation

    - Fortune 50 medical device training programs

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Ready to Accelerate Your Device Development?

"No pressure consultation with medical device documentation experts"