- Regulatory Documentation: Associated with 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

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

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

“We just wrapped up the greatest trade show we’ve ever had. I can’t tell you how strong we were, and focused.”

“We’ve acquired 3 new distributorships after putting them through an evaluation process based in great measure on our work in January. This has set the stage for an amazing year ahead, and our work with you has really given us a level of confidence to know that we can handle everything.”

“You’ve given us insight and tools to take us to new levels of success and professionalism. I can’t overestimate the value of your guidance.”

“So thank you sincerely, and know that we all hope this is only the beginning of what will be a long, fruitful, and truly enjoyable relationship with you and your company.”

In response to a 6-month engagement involving extensive process mapping, developing dozens of substantive recommendations for improving their efficiency, and deploying a global service desk.

“Ron, thank you for coming along as part of the team. Your expertise in this space has been wonderful to tap into. And please extend our thanks to you diligent team as well!”

"Ron did great. He really knows the business. We now have a great opportunity to launch a Coordination Desk that can help us immensely."

"The workshop was very enlightening and beneficial as it presented many opportunities to dig deeper, identify key focus areas and be able to discuss our pain points and barriers to execution."

"The workshop was very enlightening. Four days went by quick because so many important issues came out during the collaboration sessions. JANA Team (esp. Ron) did a great job getting all of us on track... we came prepared for process mapping and defining the future state."

"Loved the process mapping and the open discussions. Great opportunity to map out our challenges."

"You all were excellent facilitators and the agenda was well-paced and flexible."

"Thank you for spending your week with us helping us dissect a very complicated program. I look forward to working with you more through this project."