Medical Device Regulatory Consulting | Veranex iCRO

Strategic Medical Device Regulatory Consulting for Your Compliance Challenges

Navigate complex regulatory pathways with confidence. Our expert consultants accelerate your medical device journey from concept to global market success.

Master FDA, EU MDR & IVDR Requirements with Expert Medical Device Regulatory Services

Whether you're embarking on your first regulatory submission, expanding into new global markets, or pursuing indication expansions as part of a broader platform strategy, Veranex's medical device regulatory consulting team provides the strategic guidance and tactical execution you need to move confidently through every stage of the regulatory process.

Our unique combination of regulatory expertise, domain know-how, and experience collaborating with the FDA and Notified Bodies enables us to identify potential pitfalls and proactively mitigate project risks. This hard-earned knowledge allows us to define the right strategy and meet the requisite compliance standards at each relevant stage of your company and project’s lifecycle, from pre-submission planning through post-market surveillance.

FDA, EU MDR, EU IVDR, and other global markets

Global Regulatory Knowledge and Hands-On Experience

510(k), De Novo, PMA Applications, Q-Sub, Device Classification, Technical Documentation, Clinical Evaluation, Risk Management, Standards Compliance, Post-Market Surveillance, etc.

Comprehensive Coverage Across Multiple Regulatory Disciplines

Software (SaMD), Active Implantable (AIMD), In Vitro Diagnostics (IVDs), Combination Products, Drug-delivery, Surgical Instruments, Durable Medical Equipment (DME), Radiological Devices, etc.

Broad Device Type and Specialty Expertise

EU MDR Consulting

EU MDR Consulting

We cut through regulatory complexity to deliver clear, actionable strategies that get your medical devices to European markets faster and with greater confidence.

mdr-hero

EU IVDR Consulting

EU IVDR Consulting

The IVDR transition creates new challenges, but also unprecedented opportunities. We help diagnostic companies leverage these changes to establish market leadership and sustainable competitive positioning.

ivdr-hero

FDA Consulting

FDA Consulting

Veranex crafts compelling regulatory narratives that align your device's unique value with FDA expectations, creating smoother approval pathways and stronger market foundations.

fda-hero

EU Authorized Representative

EU Authorized Representative

Veranex serves as your strategic European partner, ensuring seamless regulatory compliance while actively protecting your market access through expert local representation.

eu-fda-hero-2

What Clients Say

"When embarking on our journey through evolving regulatory frameworks, Veranex was a stable, informative resource. The experienced team explained detailed guidelines and closely coached us to the point of submission, where the outcome was positive."

Dr Jack Pearson, Medical Affairs Manager at Natural Cycles

What Clients Say

"Veranex gave us confidence that the extra steps were worth it. Their expertise gave us guardrails and then they empowered us to make the right business decisions, which was invaluable."

David Goodman, VP of Marketing at Provisio

What Clients Say

"This is terrific. First of all, I am so impressed with how quickly you turned this around. This has been a big question that our team has been grappling with for a while so this is amazing to see this come together so quickly and give us a very thorough and thoughtful response."

Jennifer Fried, CEO at Flow Medical

Valerie-Defiesta-Ng

Valerie Defiesta-Ng

Sr Director, Regulatory Affairs

silvia-anghel-1

Silvia Anghel, Ph.D.

Sr Director, Quality and Regulatory Affairs

Sara Wulff

Director, Quality and Regulatory Affairs

Ready to Accelerate Your Medical Device Regulatory Journey?

Navigate global compliance requirements with confidence, reduce time to market, and establish a strong foundation for sustainable growth across all major medical device markets.

Get Your Consultation