Guiding you to global compliance
Strategic Regulatory Consulting for IVDs and Medical Devices
At CovarsaDx, our regulatory team delivers expert guidance across every stage of your IVD or medical device development program. With deep knowledge of U.S. FDA regulations and global compliance frameworks, we help sponsors navigate complex pathways—including 510(k), PMA, and De Novo—with clarity and confidence.
Whether you’re developing a novel diagnostic or expanding to international markets, our experts partner with you to craft regulatory strategies that streamline development timelines, manage risk, and support efficient product clearance or approval.
We work closely with sponsors from concept to commercialization—outlining critical milestones, defining data requirements, and ensuring your product meets FDA expectations and industry standards. Our team brings hands-on experience with FDA and other regulatory bodies, helping you anticipate challenges, avoid delays, and stay focused on getting your innovation to market.
Backed by our clinical research and quality assurance teams, CovarsaDx offers integrated support for every stage of your regulatory journey—from early trial planning through post-market activities.
Strategic Regulatory Advisory
Reimbursement Strategy (Coverage Support and Policies)
Regulatory Pre-Submissions
Regulatory Submissions (510(k), IDE, PMA, De Novo, Breakthrough Device Designation)
Reports for PMAs, IDEs
FDA Meeting Preparation
Labeling Compliance
Pre-Clinical and Clinical Trial Protocols
Analytical Study Protocols
Biocompatibility Assessments and Strategy
Why Sponsors Trust Our IVD and Medical Device Regulatory Consulting Services
At CovarsaDx, we understand the evolving complexity of FDA regulations and global market requirements. Our regulatory consultants stay ahead of industry trends, FDA guidance updates, and international compliance changes—ensuring your IVD or medical device remains aligned with current expectations.
With deep experience in IVD and medical device regulatory consulting services, we help sponsors anticipate and overcome regulatory challenges. Our established working relationships with FDA reviewers and other regulatory bodies allow us to guide submissions efficiently and reduce delays—accelerating your path to market.
Key Benefits of Our Regulatory Services:
- Proven success across 510(k), De Novo, and PMA submissions
- Strategic support from clinical trial design to post-market surveillance
- Custom regulatory pathways tailored to your product, business model, and risk profile
- Hands-on guidance for FDA meetings, submission packages, and compliance documentation
Ready to Navigate the Regulatory Landscape?
From pre-submission strategy to post-market support, CovarsaDx provides expert-driven regulatory consulting for IVD and medical device innovators. Let us help you move from uncertainty to approval with clarity, confidence, and speed.
Partner with CovarsaDx to streamline FDA approvals, ensure global compliance, and bring your product to market successfully.