Fast Track Your
FDA Regulatory Approval
Accelerate medical device launches with proven, strategic guidance
from a recognized FDA-accredited team of experts
You’re Developing a Medical Device to go to Market
We’ll help you find the most efficient pathway to get there.
Defining the optimal regulatory strategy early is the key to getting your new or modified medical device product to market faster.
With deep technical expertise and a strategic approach, we help you navigate the regulatory process with fewer delays and greater confidence.
How We Do It
Our approach combines technical domain expertise, product development insight, regulatory strategy, and market intelligence to accelerate first marketability.
Regulatory Strategy
Just beginning, or require clarity on your regulatory pathway? Start with our foundational regulatory strategy services to chart the most effective course to market readiness.
Quality Management System & Technical Documentation Support
Ensure your QMS is in place and your DHF is complete with services like audits, assessments, design reviews, and documentation creation or updates.
FDA Submission Support
Navigate the entire FDA submission process with clear guidance on Q-Submission, eStar review or assembly, FDA additional information requests, or deficiencies.
Post-Market Support
After approval, get support with company and product registrations and ongoing compliance so your product stays current with FDA requirements.
-
Featured Case Study
From Submission to Clearance in 60 Days: How Medical Templates Fast-Tracked FDA Approval with 3P510(k)
Read the full story: From Submission to Clearance in 60 Days: How Medical Templates Fast-Tracked FDA Approval with 3P510(k)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…
Our Domain Expertise
Our extensive portfolio—100+ projects across 50 trusted clients—highlights
our experience and consistent delivery in the medical device industry.
About
BeanStock Consulting
An FDA-Recognized 510(k) Third Party Review Organization
At the heart of our work is a promise—to partner with you through the complexities of medical device regulation with transparency, trust, and unmatched expertise, helping bring your product to market without unnecessary delays.
Understanding your business, product, customer, and regulatory requirements to meet your needs as effectively as possible
Simplifying the complex so you understand what’s ahead and can take the right steps toward FDA approval
Staying focused on your vision and leveraging our expertise to deliver a safe and effective compliant product that reaches the people who need it
“Bedrock’s reusable platform allowed us to launch a fully custom clinical analysis solution—integrated with our own backend—in just three months. The deployment was seamless, the code handoff effortless, and the platform’s built-in compliance and scalability mean we can grow without starting from scratch.”
CONFIDENTIAL
Head of Software Engineering, Global Diagnostics, Global Therapeutics Manufacturer
“Thank you, BeanStock Ventures, for the successful collaboration in software development and managing a highly complex program. We were impressed with the successful integration of your experts with our Research and Development team and the achievement of end-to-end integration in six months. Your creation of a custom team to complement our team and provide the leadership in software strategy; designing our interface and leading the integration of the secondary analysis software and planning for a new life science instrument across four organizations was professional, effective, and aligned with our business needs. I would highly recommend partnering with BeanStock Ventures on innovation and software product development in life sciences, biotechnology, or medical devices.“
Mimi Healy
Former CEO, Lasergen, Inc (Acquired by Agilent).
“The Software Architecture template was a massive time-saver for us. The document is comprehensive, clearly organized, and gave my team the guidance necessary to customize our document by emulating the original content structure.”
Peter Holmes
COO, Barefoot Solutions
“Thank you, BeanStock Ventures, for being a key and valued contributor to the success of our recent 510K submission. The collaboration with our regulatory, quality partners and product development team could not have gone better. BeanStock Ventures deep understanding of the medical device industry and regulatory landscape helped deliver a professional, thorough software process and thereby a finished product for submission. Your careful oversight and guidance aligns with our corporate objectives and allowing us to achieve our key milestones. We look forward to working together on our future software quality and regulatory needs.”
Paul DiPerna
CEO, Modular Medical and Founder of Tandem Diabetes
“The premium DHF templates are pretty awesome. These helped our team do the right processes very quickly without having to develop anything in-house. The documents were very mature, had great examples, and the color coordination within each template was very helpful to spell out exactly what information was needed in our documents.
Being our first time with true software product development, we appreciated that the tools provided by BeanStock Ventures’ DIY Software Kit integrated with our existing processes so that we did not need to migrate. We were able to reach more mature processes quickly.”
Matthias Merten
Director, Systems Engineering, Resilience
Explore Our Latest Resources
-
How to Clear a Software Medical Device with the FDA
Chart Your Course to Regulatory Success
Let’s talk through your products and goals, then build a regulatory strategy that gets your product approved—faster.
