Your US Agent in clinical research, regulatory & quality solutions
We can serve as your US agent to the FDA.
Navigating the Labyrinth:
Your Guide to a Winning Medical Device Regulatory Strategy
Don’t let regulations hold you back. Partner with IVD Regulatory Advisors and bring your life-changing IVD device to market faster and more efficiently.
Strategy
No matter how early or late you are in development, we can help you strategize the next steps.
Study Design
Resources are limited. Let us help you strike a balance between available resources and fulfilling study design requirements.
Partnerships
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Pre-submissions
Let us help write your pre-submission questions, and study risk determinations.
Breakthrough Device Designation
We have extensive experience with breakthrough device designation requests.
Marketing Applications
Let us help with writing and submitting investigational device exemptions, de novo, 510(k), and PMA submissions. We can also represent your company to the FDA.
IVD Regulatory Advisors deliver the best solutions in the medical device industry.
We are excited to bring our decades of research, regulatory, FDA acumen, and industry experience together to collaborate with developers of in vitro diagnostic devices, guiding them through the intricate landscape of regulatory strategies. We strive to foster advancements in healthcare by providing comprehensive services that facilitate seamless interactions with the FDA. Let our consultants guide you today.
We can guide you from ideas to winning marketing approval.
We have seen it all.
Let us help you with analytical and clinical validation study designs.
We can work directly with the FDA on your behalf.
Let us help you write your regulatory documents for FDA.
What Our Clients Say
