510(k) & CE Mark Submission Consulting | Medical Device Regulatory Strategy – Boulder Solution

Eliminating the “Request for Additional Information” (AI)

A regulatory submission is not a filing—it is an argument. At Boulder Solution, we don’t just compile data; we architect defensible evidence. Most delays in the 510(k) or CE Mark process stem from fragmented data or Substantial Equivalence arguments that don’t hold up under FDA or Notified Body scrutiny.

Regulatory Pathways & Submission Types

Our Submission Expertise Covers:

Submission Documentation:

Substantial Equivalence (SE) Determination
Predicate Device Comparison
Indications for Use Statement
Device Description & Specifications
Performance Testing & Bench Testing
Biocompatibility Testing (ISO 10993)
Sterilization Validation (ISO 11135, ISO 11137)
Electrical Safety Testing (IEC 60601)
Software Documentation (IEC 62304)
Usability Testing (IEC 62366 / Human Factors)
Clinical Evaluation Reports (CER)
Risk Management Files (ISO 14971)
Labeling & Instructions for Use (IFU)

US FDA Pathways:

510(k) Premarket Notification (Traditional, Special, Abbreviated)
De Novo Classification Request
Premarket Approval (PMA)
Humanitarian Device Exemption (HDE)
Investigational Device Exemption (IDE)
Pre-Submission (Q-Sub) Meetings
eSTAR Electronic Submission System

EU & International Pathways:

CE Mark Technical File (EU MDR 2017/745)
CE Mark Transition from MDD to MDR
UKCA Mark (UK Conformity Assessed)
Health Canada Medical Device License (MDL)
TGA (Australia) Conformity Assessment
PMDA (Japan) Marketing Approval
ANVISA (Brazil) Registration

Testing & Validation Support:

Design Verification & Validation (V&V)
Performance Testing Protocols
Animal Testing & Preclinical Studies
Clinical Trial Design & Monitoring
Statistical Analysis Plans
Comparative Effectiveness Studies

Post-Market Requirements:

Post-Market Surveillance (PMS) Plans
Periodic Safety Update Reports (PSUR)
Medical Device Reporting (MDR)
Summary of Safety & Clinical Performance (SSCP)
Post-Approval Studies

Strategic Classification & Predicate Selection

We analyze your startup’s current stage and market potential to create a customized roadmap for sustainable scaling.

510(k) Preparation & eSTAR Filing

Full-service compilation of Traditional, Abbreviated, or Special 510(k)s using the latest FDA digital standards. We manage eSTAR submissions and coordinate with FDA reviewers to accelerate clearance timelines.

EU MDR Technical File Architecture

Navigating the complex transition from MDD to MDR with robust Clinical Evaluation Reports (CER), Post-Market Surveillance (PMS) plans, and Periodic Safety Update Reports (PSUR). We build Technical Files that satisfy Notified Body expectations.

De Novo & PMA Support

For truly novel innovations, we manage the high-stakes data requirements and formal FDA interactions. Scientific rationale development, clinical trial design support, and Pre-Market Approval application assembly.

We lead the "Pre-Sub" meeting with FDA to gain early alignment, reducing the risk of unexpected testing requirements later. Meeting preparation, FDA interaction strategy, and formal meeting minutes documentation.

We analyze your startup’s current stage and market potential to create a customized roadmap for sustainable scaling.

Regulatory Planning

Early Concept Design & Development

Regulatory Strategy

QMS Implementation

Project Development & Precision Manufacturing

Supply Chain & Logistics

Get a free consultation?

Our Head Regulatory Consultant

First-Time Clearance

Strategic submissions that eliminate AI requests

Scalable QMS Architecture

Built for startups, ready for enterprise

Cutting Edge Design without the Stress

Got Questions?

FAQ:

What causes most 510(k) submissions to be delayed or rejected?

Most delays are caused by unclear predicates, incomplete testing, or inconsistencies between claims, labeling, and evidence. These issues are usually preventable with early regulatory planning.

When should regulatory strategy begin for a 510(k) or CE Mark?

Regulatory strategy should begin before testing starts. Early planning ensures the right evidence is generated and prevents rework late in the submission process.

Can you help after an FDA RAI or hold is issued?

Yes. We analyze the FDA’s questions, identify root causes, and build a structured response package that directly resolves each deficiency.

Do FDA and EU submissions require different evidence?

Often yes. While some data overlaps, FDA and EU regulators evaluate risk, clinical evidence, and standards differently. We align submissions without duplicating unnecessary work.

510(k) & CE Mark Submission Consulting | Medical Device Regulatory Strategy

Eliminating the "Request for Additional Information" (AI)