EUDAMED mandatory from 28 May 2026. FDA QMSR Final Rule effective February 2026. MHRA International Reliance routes arriving. CVX Corven MedTech actively tracks every major regulatory market — so your submission strategy is always built on what regulators require today, not yesterday.
End-to-end regulatory pathway planning and submission support across seven global markets.
We provide strategic guidance and technical support for navigating the complex US regulatory landscape — from 510(k) pre-submissions through to PMA approval.
Effective February 2026, the FDA's Quality Management System Regulation replaces the previous 21 CFR Part 820 with requirements aligned to ISO 13485. All 510(k) and De Novo submissions must now reference the new QMSR framework.
From 28 May 2026, four EUDAMED modules become mandatory: Actor Registration, UDI/Device, Notified Bodies & Certificates, and Market Surveillance. New MDR/IVDR devices must be registered before first placement on the EU market. Legacy devices must be registered by 28 November 2026.
Expert support for the European Union Medical Device Regulation, ensuring your device meets the highest safety and performance standards for the EU market.
The MHRA is introducing International Reliance routes in 2026/2027, allowing devices approved by the FDA, Health Canada, EU, and Australia to gain streamlined GB market access. CE-marked devices remain accepted in Great Britain until 30 June 2030.
New Post-Market Surveillance requirements effective June 2025 introduced tighter incident reporting timelines and mandatory PSURs for higher-risk devices.
Plan Your UK StrategyUK regulatory landscape restructuring — new four-class IVD risk framework through mid-2027. MHRA's IVD Road Map (December 2025) outlines a streamlined path for medical devices already cleared in other major markets.
You need a regulatory strategy that protects your vision while respecting your runway. We help early-stage ventures build submission-ready frameworks from day one.
Ensure your global presence remains unshakable. We handle the heavy lifting of multi-market submissions and regulatory remediation for complex portfolios.