Regulatory Success Starts Here
Navigate the regulatory process confidently with expert guidance
every step of the way
Your Path to Regulatory Approval
From early strategy to post-market support, our FDA-accredited experts helps
you accelerate development and ensure compliance.
Regulatory Strategy
We help you define the optimal regulatory pathway — 510(k), De Novo, or PMA — based on your product’s regulatory requirements, business model, and target markets.
Regulatory Classification
Determine your device’s classification to define the appropriate regulatory pathway.Pre-Submission Meeting Strategy
Prepare for successful FDA meetings that generate valuable feedback.Go-to-Market Planning (U.S. + International)
Plan ahead to launch smoothly in every market.Product-specific Guidance & Special Controls
Identify product-specific considerations with confidence.
Quality Management System & Technical Documentation Support
We help you build, audit, and refine your QMS and technical documentation to meet FDA, ISO 13485, and EU MDR requirements — whether you’re starting from scratch, preparing for inspection, or responding to regulatory feedback.
QMS Gap Analysis & Implementation
Identify weaknesses and implement a tailored, audit-ready quality system.Design History File (DHF) Development
Develop a DHF to demonstrate compliance with design control requirements.Document Control, Training & SOPs
Ensure your teams follow current, clearly written procedures with reliable training.Technical Documentation Audits & Remediation
Review and revise technical files to meet regulatory and technical merit.
FDA Submission Support
From planning through delivery, we guide your submission process to meet regulatory expectations in the U.S. and abroad.
FDA 510(k), De Novo, & PMA Submissions
Strategize, prepare, and submit with clarity and precision.EU MDR/IVDR Technical Documentation
Build structured, regulator-ready technical files for CE marking.Submission Authoring & Formatting
Create clear, consistent documents tailored to reviewer expectations.Regulatory Agency Interaction
Navigate inquiries from FDA and Notified Bodies with expert support.
Post-Market Support
Ensure long-term compliance, inspection readiness, and ongoing regulatory obligations.
Device Registration
Maintain active FDA device listings and establishment registrationsPost-Market Surveillance & Safety Reporting (PMSR, PSUR, Vigilance)
Track performance, manage risks, and meet global reporting requirementsCAPA, Nonconformance & Field Action Management
Identify and correct systemic issues with clear root cause analysisPost-Market Cybersecurity & Risk Updates
Monitor, assess, and update cybersecurity risk management documentation
What to Expect When You
Work With Us
A Clear Path Forward
Get a step-by-step plan that fits
your product and goals.
Dedicated Guidance
Partner with experts who are by
your side from start to finish.
A Focus on Education
Learn the “why” behind every step,
not just what to do.
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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…
From strategy to submission—accelerate your FDA path with confidence.
Our regulatory services are designed to fast-track your device from concept to clearance. Whether you need support with early regulatory strategy, design history file creation, or cybersecurity validation, our team delivers FDA-aligned, audit-ready solutions that eliminate delays and drive rapid submission success.
A Proven Path to Success
From design and development through market launch, our FDA-
accredited experts are here to guide you every step of the way
Assessment
Identify needs,
gaps, risks, & opportunities
Strategy
Program framework to establish the team and understand the journey
Team Creation
Align domain expertise, address knowledge gaps, and leverage synergies
Immersion
Deep-dive collaboration sessions
Execution
Incremental milestones to achieve long-term goals
Delivery
Usable set of deliverables at each increment
Applying Our Expertise to
Your Unique Situation
With over 100 completed projects under our belt, we have the tools,
resources, and expertise to help you achieve your goals.
