How a Medical Device Startup Achieved FDA Clearance & Secured Market Success

A promising medical device startup developed a groundbreaking wearable designed to help patients with chronic respiratory conditions. The product had immense potential, but the company faced a critical barrier—navigating the complex FDA approval process.

With limited resources, no in-house regulatory expertise, and pressure from investors to demonstrate compliance progress, they needed a clear strategy to move forward. Without FDA clearance, they couldn’t legally market or sell their device, putting their entire business at risk.

How Araujo Healthcare Consulting Helped:

Regulatory Strategy & FDA Classification:
Conducted a full regulatory assessment to determine the appropriate classification and approval pathway.
Identified similar cleared devices to streamline the approval process.

Pre-Submission & Compliance Framework:
Assisted in pre-submission communication with regulators to clarify compliance expectations.
Developed a risk management plan to align with industry standards for safety and performance.

Quality System Implementation:

Established a structured compliance framework to meet regulatory requirements.
Developed SOPs for product testing, documentation, and post-market monitoring.

Clinical Validation & Submission Support:

Guided the client through a structured data collection strategy to support their application.
Assisted in compiling and submitting the necessary regulatory documentation.

FDA Approval & Market Entry:

Ensured a smooth review process by proactively addressing regulatory feedback.
Developed a post-approval compliance plan to support continued growth and expansion.

Results & Impact:

✅ FDA Clearance Achieved in Six Months – Enabling full U.S. market entry.
✅ Investor Confidence Secured – Resulting in a multi-million-dollar funding round.
✅ Successful Product Launch – Generating strong initial sales and market traction.
✅ Scalability & Expansion – Laying the foundation for international market entry.
Conclusion:

This project highlights how expert regulatory consulting can transform an overwhelming process into a strategic advantage. By helping this startup navigate complex compliance hurdles, Araujo Healthcare Consulting played a key role in positioning them for long-term success.