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1500+
Total Number of FDA Submissions and Amendments Worked
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20+ Disciplines
Deep expertise across 20+ different regulatory disciplines
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Broad device type expertise
Software (SaMD), Active Implantable (AIMD), In Vitro Diagnostics (IVDs), Combination Products, Drug-delivery, Surgical Instruments, Durable Medical Equipment (DME), Radiological Devices, etc.
Provisio Medical's FDA Clearance
Situation
Provisio Medical was developing a novel IVUS (Intravascular Ultrasound) device, the Provisio™ SLT IVUS™ System, which uses A-mode ultrasound to provide real-time dimensional measurements of the vessel lumen. This device was unique because it integrated into a support crossing catheter and provided numerical data instead of traditional grayscale images.
The main challenge was proving the accuracy of the device's measurements to the FDA, as physicians were accustomed to interpreting images. The FDA challenged Provisio during a Pre-Submission meeting to scientifically demonstrate the validity of their measurements.
Successes
- Successfully demonstrated the accuracy of the device's measurements to the FDA by developing a sophisticated cadaver model that showed equivalence to traditional IVUS technology without needing human clinical trials.
- Obtained FDA clearance for the Provisio™ SLT IVUS™ System.
Services by Veranex
Veranex partnered with Provisio to obtain FDA clearance. Our teams provided cross-functional expertise in the following areas:- Regulatory strategy and consulting
- Preclinical studies
- Usability studies
- Quality assurance and engineering
510(k) Certification of a Laparoscopic Retrieval Bag
Situation
A client had spent three years developing multiple sizes of a novel laparoscopic specimen retrieval bag. They partnered with Veranex’s product design team to finalize the device design and initially planned to submit all sizes together through a Traditional 510(k). However, when some testing results were delayed, they turned to Veranex’s regulatory team to identify an expedited pathway to market.
Successes
Veranex's regulatory experts quickly devised a phased strategy, recommending a Traditional 510(k) for the primary bag size with complete testing, while positioning additional sizes for subsequent Special 510(k) submission. Our team collaborated closely with the client to draft and file the 510(k), which passed FDA's Refuse to Accept (RTA) review without issues. The submission was cleared in well under 90 days with only one Additional Information request and no interactive review questions or comments — a notably efficient process.
Services by Veranex
- Regulatory strategy development, including expedited pathway identification
- Full 510(k) submission preparation and FDA submission management
- Risk assessment and documentation support
- Human factors engineering guidance
- Sterilization and packaging validation consulting
Quality Consulting
Ensure your regulatory submissions are backed by robust quality processes that satisfy both FDA requirements and international standards —perfectly complementing your FDA medical device consulting strategy with comprehensive quality systems expertise.
Product Development and Engineering
Successfully complete the required FDA deliverables with an experienced team to navigate the complexities with effective execution.
Clinical Research Services
Seamlessly integrate your regulatory strategy with clinical execution through our specialized Medical Device CRO services. Ensuring your FDA submission path is supported by strategically designed studies that meet submission requirements and your commercial objectives.
MDR Consulting
Expand beyond FDA compliance with our MDR consulting services, creating a harmonized regulatory approach that aligns your FDA medical device strategy with European requirements for seamless global market access.
