At ProRelix Research, a leading Clinical Research Organization in the USA, we specialize in delivering end-to-end clinical development solutions tailored for 510(k), PMA, and De Novo clinical trials. Our team brings deep regulatory expertise, operational excellence, and therapeutic insight to support device manufacturers through every phase of their product’s FDA approval journey.
Whether you’re working on a Class II orthopedic implant or an innovative Class III cardiovascular device, our clinical development services in the US ensure precision, compliance, and speed in execution. From concept through commercialization, we offer full-spectrum CRO solutions designed to meet stringent FDA standards.
Navigating Regulatory Pathways with Confidence
510(k) Clinical Trials
510(k) is the most common regulatory submission route for Class II medical devices that demonstrate “substantial equivalence” to an existing, legally marketed device.
As a US-based clinical research company, ProRelix Research supports you by:
- Identifying suitable predicate devices.
- Designing and conducting comparative studies.
- Managing biocompatibility, usability, and performance testing.
- Preparing technical documentation and submission packages.
- Ensuring GCP-compliant data collection and monitoring.
Our deep regulatory insight and clinical operations network make us the ideal CRO specializing in oncology trials in the USA and across other high-demand therapeutic areas, helping accelerate your 510(k) submission process with confidence.
PMA Clinical Trials
PMA (Premarket Approval) is the FDA’s most stringent pathway, required for high-risk Class III devices that sustain or support human life or present a significant risk to health.
Our PMA trial services include:
- IDE (Investigational Device Exemption) support.
- Full clinical trial management solutions in the USA, from site selection and initiation to monitoring and data analysis.
- Safety surveillance, interim analyses, and data reporting.
- Regulatory strategy, pre-submission meetings, and FDA communications.
With experience managing large-scale, multi-center PMA trials, we understand what it takes to generate the robust safety and effectiveness data required for FDA approval.
De Novo Clinical Trials
The De Novo pathway is ideal for innovative, low- to moderate-risk devices that lack a suitable predicate. As a top provider of biotech clinical trials in the USA, we offer strategic and operational support to bring your breakthrough technology to market.
We assist with:
- Risk classification and intended use analysis.
- Designing clinical evidence plans specific to novel technologies.
- Managing data collection for benefit-risk evaluations.
- Drafting and submitting De Novo requests.
- Planning for post-market surveillance and follow-up.
For companies launching first-of-their-kind devices, our experience and partnership approach help minimize delays and optimize submission outcomes.
Why Choose ProRelix Research?
As a premier provider of clinical trial services in the USA, we are trusted by startups, medtech innovators, and global manufacturers for our:
Regulatory Mastery
We bring extensive knowledge of FDA regulations including 21 CFR Parts 11, 50, 56, 812, and 814, along with ISO 14155 and ICH-GCP guidelines. Our team helps you navigate every step of the approval process with clarity and assurance.
Customized, Device-Specific Trial Design
From surgical tools to diagnostic software, we design trials tailored to your device class, risk level, and target patient population. We bring the same rigor to biotech clinical trials in the USA as we do for complex implants and digital health technologies.
Nationwide Clinical Operations
As a US-based clinical research company, we maintain a vast network of investigators, trial sites, and institutional partners to execute studies across North America with speed and precision.
End-to-End CRO Services
Our comprehensive service portfolio includes:
- Clinical Trial Feasibility & Protocol Development
- Regulatory Affairs & Submissions
- Site Management & Patient Enrollment
- Data Management & EDC Implementation
- Biostatistics & Statistical Consulting
- Medical Writing & Safety Monitoring
- FDA Meeting Support & Post-Market Surveillance
Explore more about our end-to-end CRO services in the USA designed to move your device through the regulatory pathway and into clinical practice.
Technology-Driven Solutions
We integrate EDC platforms, remote monitoring tools, and centralized data systems to streamline operations and provide real-time visibility into trial progress. Our tech-enabled approach ensures transparency, speed, and compliance.
Your Innovation Deserves the Right Partner
At ProRelix Research, we combine scientific precision with regulatory know-how to make your journey through 510(k), PMA, or De Novo pathways seamless and successful. As a trusted CRO specializing in oncology trials in the USA and beyond, we bring the experience and resources needed to deliver on every milestone—on time and with confidence.
Contact us today to learn how our clinical trial services in the USA can support your next breakthrough medical device or biotech innovation.
