FDA Regulatory Solutions for Laboratory Developed TeSTS
Our Vision
Our Approach
Our Vision
At LDT Regulatory Solutions, our goal is to help LDT labs of all sizes adopt in vitro diagnostic (IVD) medical device compliance requirements in alignment with FDA's May 2024 final rule. We aim to ensure minimal disruption for our clients while establishing a customized, affordable medical device compliance framework to support registrations.
Our Team
Our Approach
Our Vision
Our team is comprised of highly skilled regulatory affairs professionals who have extensive experience with regulated medical devices and FDA negotiations. We are RAPS-certified experts with 15+ years of regulatory affairs experience who have specific expertise with in vitro diagnostic (IVD) medical devices.
Our Approach
Our Approach
Our Approach
Our strategy to ensure your compliance involves:
- Regulatory Gap Assessment and Strategic Planning
- Compliance implementation and training
- Submission and Registration