Summary
Medical Templates AG, a Swiss-based MedTech innovator, had a strong internal team, an established QMS, and a well-prepared FDA submission package for its image-guided software system, Puncture Cube. Facing tight timelines due to an upcoming trade show, the company partnered with BeanStock Ventures to expedite clearance. By leveraging our FDA-accredited 3P510(k) review pathway and efficient coordination with the FDA, Medical Templates secured market clearance in just 60 calendar days—cutting traditional review time nearly in half and enabling a successful U.S. product launch.
Challenge
Although Medical Templates AG had a strong internal team and robust QMS in place, this was their first FDA submission—introducing uncertainty around classification, scope, and documentation expectations. Their software product, Puncture Cube, included both a Class I support platform and a Class II image-guided needle navigation plugin, with complex integration of a third-party DICOM viewer. This architecture raised nuanced regulatory questions and required careful labeling and risk control alignment.
Compounding the complexity, the team faced a tight deadline tied to a major trade show, making speed to clearance critical for launch visibility and commercial traction.
BeanStock Ventures Fast Track Solution
FDA-Accredited Third Party Review + Submission Readiness
🧭 Regulatory Strategy
- Defined classification under LLZ with supporting predicate mapping
- Conducted pre-submission review of labeling and indication language
- Guided integration of third-party viewer and the puncture cube while maintaining compliance
📄 Documentation & Compliance
Built submission package using Grassroots DHF Templates
- Created and validated all required documentation:
- Software Development Plan (SDP)
- Risk Management File (RMF)
- Cybersecurity Summary
- Software Requirements + V&V Matrix
- Ensured alignment with IEC 62304, 14971, and 21 CFR 820
🚀 3P510(k) Execution
- As an FDA-accredited Third Party Review Organization, BeanStock Ventures conducted the full 510(k) review
- Managed direct communication with FDA
- Delivered structured decision memo with no major deficiencies
Outcome
| Metric | Timeline |
|---|---|
| Submission to FDA | Day 0 |
| Review Completed by BSV | Day 47 |
| Final FDA Decision | Day 60 |
| Total Time to Clearance | 60 calendar days |
🧠 Why 3P510(k)?
- FDA-Accredited Review Authority – Recognized by the FDA to conduct official third-party reviews for over 250+ Class II product codes.
- Proven Speed to Clearance – Achieve U.S. market clearance in as little as 60 days, nearly cutting traditional timelines in half or MORE.
- Ideal for Well-Understood Devices – Perfect for Class II devices with clear predicates and established safety profiles.
- Direct FDA Coordination – Manage communication minimizing delays and uncertainty.
- Business-Driven Advantage – Accelerates launch timelines for events, trade shows, and competitive windows where every week counts.
📩 Want your device cleared in 60 days?
Start your submission with BeanStock Consulting.
3P510K@beanstockventures.com