From Concept to Compliance — We Engineer Your Path to Market
CVX Corven MedTech is a specialist consulting firm helping medical device startups navigate the complex regulatory landscape — from device strategy and design controls to FDA 510(k) submissions and EU MDR compliance. Founded by a senior MedTech professional with over two decades of hands-on experience at Johnson & Johnson, Boston Scientific, Cook Medical, and DePuy Synthes.
20+
Years of Industry Experience
J&J · Boston Scientific · Cook Medical · DePuy Synthes
Alumni-Founded
FDA · EU MDR · UKCA · EAEU · ANVISA · PMDA
Global Regulatory Coverage
4
Global Offices
Years of Industry Experience
20+
J&J · Boston Scientific · Cook Medical · DePuy Synthes
Alumni-Founded
FDA · EU MDR · UKCA · EAEU · ANVISA · PMDA
Global Regulatory Coverage
Global Offices
4
Expertise Forged Inside the World's Leading MedTech Companies
Our founder has held senior regulatory, quality, and NPD project management roles at Johnson & Johnson, Boston Scientific, Cook Medical, and DePuy Synthes — four of the most rigorous regulatory and quality environments in the global medical device industry. With over 20 years of hands-on experience spanning FDA pathways, EU MDR, UKCA, IVDR, EAEU, ANVISA, Canada Health, and PMDA (Japan), that institutional depth now powers the strategic advisory we deliver to startups.
Johnson & Johnson
Senior Regulatory & Quality
Cook Medical
Time-to-Market Reduction
Boston Scientific
100% SaMD Compliance
DePuy Synthes
MDR Transition Expertise
Four Areas Where We Go Deepest
What We Do
We partner with startups and emerging medical device companies to provide deep technical expertise and strategic regulatory guidance at every stage of the lifecycle.
◈
Device Strategy & Classification
Defining the most efficient regulatory path, identifying predicate devices, and establishing early-stage design control frameworks.
FDA PATHWAY
CLASS I/II/III
⚙
Quality Management Systems
Building ISO 13485:2016 compliant systems that are scalable, audit-ready, and tailored to startup agility requirements.
ISO 13485
QMS BUILD
🛡
Regulatory Submissions
End-to-end execution of FDA 510(k), De Novo, and PMA submissions, along with EU MDR and global market clearances.
510(K)
CE MARKING
🌐
Post-Market & Clinical
Strategic surveillance, clinical evaluation reports (CER), and vigilance system management for sustained global compliance.
VIGILANCE
PMS DATA
Not sure which service applies to your device? We'll help you figure it out.
Why CVX Corven MedTech
20 Years. Four Companies. One Standard of Excellence.
Our founder has held senior regulatory, quality, and NPD project management roles at Johnson & Johnson, Boston Scientific, Cook Medical, and DePuy Synthes—four of the most rigorous regulatory environments in the world.
Johnson & Johnson
EAEU Registration — $40M Revenue Protected
Led the urgent registration of high-risk orthopedic implants under new EAEU regulations, ensuring zero market disruption for a critical product line.
Boston Scientific
SaMD Global Deployment — 100% Compliance
Orchestrated the regulatory strategy for a Software as a Medical Device (SaMD) platform, achieving simultaneous clearance in FDA and EU MDR markets.
Cook Medical
Combination Products — 10–15% Faster Time-to-Market
Implemented a streamlined design control process for drug-device combination products, accelerating global submissions without compromising quality.
Global Offices, Local Insight
Regulatory and quality expertise across the USA, Europe, UK and India.
🇺🇸 New Jersey, USA
🇮🇪 Dublin, Ireland
🇬🇧 London, UK
🇮🇳 Indore, India