Your FDA Submission Team

On-Demand FDA Device/Drug Experts

PMCF Pricing

Why Us?

US Based
Global Presence

Battle-Tested
FDA Submission Experts

Industry Leading Service
and Project Management

Our Services

Pre-submission Consulting

πŸ” Guidance on the Best Regulatory Pathway
Determine if 510(k) or another pathway like De Novo is right for your device, ensuring a smooth regulatory strategy from the start.

Gap Analysis and Readiness Assessment

πŸ“Š Identifying Pathways to Compliance
A thorough evaluation of your documentation against FDA requirements to pinpoint gaps and streamline your submission process.

Biocompatibility Assessment

πŸ”¬ Ensuring Biological Safety
Navigate biocompatibility testing requirements with expert advice, ensuring your device meets all ISO 10993-1 standards.

Software Validation Support

πŸ’» Compliance for Software-Driven Devices
From software lifecycle management to validation in compliance with FDA guidance, we ensure your device’s software components are fully vetted.

Clinical Evaluation and Clinical Trial Design

πŸ“ Robust Clinical Trial Strategies
Expert support in designing and implementing clinical trials that provide the evidence needed for your 510(k) submission.

Quality System Implementation

βš™οΈ Quality Management System Excellence
Guidance on implementing a compliant Quality Management System (QMS) in line with 21 CFR Part 820, essential for all 510(k) submissions.

Usability Engineering

πŸ‘₯ Focusing on User Safety and Effectiveness
Design and document usability studies that meet FDA’s human factors requirements, ensuring your device performs safely in real-world scenarios.

Electrical Safety and Performance Testing

⚑ Electrical Safety Assurance
Expert advice on electrical safety and EMC standards and testing, tailored to your device’s specifications and use environments.

Labeling and Promotional Material Review

🏷️ Clear and Compliant Communication
Ensure your labeling and promotional materials meet FDA standards, accurately reflecting your device’s intended use and limitations.

FDA Communication and Submission Management

πŸ“ž Your Liaison with the FDA
Manage the entire 510(k) submission process, from preparing your application to responding to FDA queries, with our experienced regulatory professionals.

Post-market Surveillance Planning

πŸ”Ž Ongoing Compliance and Improvement
Develop and implement comprehensive post-market surveillance plans, collecting critical data on device performance for continuous improvement.

Each service is backed by our commitment to your success, offering not just solutions but a partnership to navigate the regulatory landscape. Contact Us for a consultation and let us tailor our services to your success.

Let’s Talk FDA

Looking for pricing, more details, or some advice on your current projects?
Drop us a line for a free consult.