About CVX Corven MedTech

Regulatory Complexity Is the Biggest Risk to Your Device Reaching Market. We Exist to Eliminate It.

Whether you are a startup navigating your first FDA pathway or a global pharmaceutical company entering the device space — the regulatory challenges are the same. The difference is having the right advisory partner. CVX Corven MedTech was built to be exactly that.

20+

Years of Industry Experience

Global Regulatory Markets

Global Offices

Our Mission

Engineers of Human Trust

To bridge the gap between groundbreaking medical concepts and the stringent realities of global compliance, ensuring that life-saving technologies reach patients with uncompromising quality and speed.

Our Vision

The Compliance Standard

To be the world's most trusted partner for medical device startups, redefining regulatory strategy as a core competitive advantage that empowers engineers to focus on what matters: solving human health challenges.

"Reliability isn't a feature in MedTech; it's a foundational human right. Our conviction is that compliance should never be an obstacle to innovation, but the very vessel that carries it safely to those in need."

Who We Serve

Partners in Every Breakthrough

Venture-Backed

Pre-Seed & Seed Startups

Helping founding teams navigate classification and first-round regulatory strategy before significant capital deployment.

Strategy First

Series A/B

NPI & Scaling Teams

Executing full submission files and building robust QMS frameworks as you transition from prototype to clinical validation.

Audit Ready

Enterprise

Clinical Spin-Offs

Providing specialized regulatory oversight for internal ventures and spin-offs within established medical technology firms.

Specialist Ops

How We Work

The Architecture of Trust

We don't just clear hurdles; we build the frameworks that transform regulatory compliance from a barrier into a definitive competitive advantage.

Our Philosophy

Safety by Construction

Our methodology is rooted in the belief that reliability is a foundational right. We integrate clinical insights with regulatory rigor from day one of development.

01 Radical Integrity We hold our work to the highest clinical standards, ensuring that data is never just a number, but a patient's promise.

02 Operational Rigor Every submission is a masterpiece of technical precision, leaving no room for ambiguity or unexpected feedback.

03 Agile Compliance We navigate the fluid landscape of global standards with speed, adapting to regulatory shifts before they impact milestones.

04 Human-Centric Strategy Innovation is only successful if it is accessible. We keep the end-user clinical experience at the heart of our strategy.

05 Proactive Partnership We don't just solve problems; we foresee them, building pre-emptive shields into your QMS and clinical plans.

06 Future-Proofing We build compliance assets that grow with your company, from seed stage prototypes to enterprise-level clinical fleets.

Leadership

Founded by a 20-Year Medical Device Industry Veteran.

The expertise behind CVX Corven MedTech was built from the inside — across senior regulatory, quality, and NPD roles at the world's most demanding medical device companies.

Founder & Managing Director

Chintan Shah

A senior medical device professional with over 20 years of direct industry experience across regulatory affairs, new product development, quality management, and product development — at some of the most respected names in the global medical device industry.

That depth of experience — spanning combination products, SaMD, implants, IVDs, and drug delivery systems — now powers the strategic advisory CVX Corven MedTech delivers to every client engagement.

Career

Johnson & Johnson

Senior Regulatory & NPD · Jacksonville, USA

Boston Scientific

Contract PM · Digital Health / SaMD · Ireland

Cook Medical

Contract PM NPD · Combination Products · Ireland

DePuy Synthes

Senior Engineer · MDR Transition · Leeds, UK

Regulatory Markets

FDA EU MDR UKCA / MHRA IVDR EAEU ANVISA Health Canada PMDA

Device Expertise

Combination Products SaMD Implants IVDs Drug Delivery Systems Contact Lenses

Certifications

Certified Risk Manager (BSI) IEng PRINCE2

The experience behind CVX Corven MedTech spans four continents, eight regulatory markets, and over two decades of hands-on industry practice.