Global Offices, Local Insight
Regulatory and quality expertise across the USA, Europe, UK and India.
🇺🇸 New Jersey, USA
🇮🇪 Dublin, Ireland
🇬🇧 London, UK
🇮🇳 Indore, India
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.
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.
We partner with startups and emerging medical device companies to provide deep technical expertise and strategic regulatory guidance at every stage of the lifecycle.
Defining the most efficient regulatory path, identifying predicate devices, and establishing early-stage design control frameworks.
Building ISO 13485:2016 compliant systems that are scalable, audit-ready, and tailored to startup agility requirements.
End-to-end execution of FDA 510(k), De Novo, and PMA submissions, along with EU MDR and global market clearances.
Strategic surveillance, clinical evaluation reports (CER), and vigilance system management for sustained global compliance.
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Book a Free Discovery CallOur 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.
Led the urgent registration of high-risk orthopedic implants under new EAEU regulations, ensuring zero market disruption for a critical product line.
Orchestrated the regulatory strategy for a Software as a Medical Device (SaMD) platform, achieving simultaneous clearance in FDA and EU MDR markets.
Implemented a streamlined design control process for drug-device combination products, accelerating global submissions without compromising quality.
Regulatory and quality expertise across the USA, Europe, UK and India.