Client Outcomes

Proven Pathways to Global Compliance

Explore how MedTech leaders partner with CVX Corven to navigate the world's most complex regulatory landscapes and accelerate time-to-market.

All FDA EU MDR Global

Featured Excellence

EU MDR Compliance

Securing EU MDR Approval for High-Risk Orthopedic Implants

Navigated rigorous Notified Body audits to achieve transition for a Class III product line within target timelines.

FDA Submission

Accelerated 510(k) Clearance for Cardiovascular Monitoring SaaS

Optimised software documentation and risk management files to secure clearance in record time with zero requests for additional information.

Regulatory Strategy

Unified Strategic Roadmap for Multi-Site Global Expansion

Developed a centralised QMS and regulatory framework supporting concurrent expansion into Japan, Australia, and Canada.

Further Industry Impact

Audit Excellence

Successfully Resolving FDA Warning Letters and Restarting Production

Conducted root cause analysis and deep QMS remediation to restore compliance standing and commercial operations.

Product Lifecycle

Full Post-Market Surveillance Overhaul for EU IVDR Compliance

Implemented an automated data collection and reporting system for a global diagnostics leader to meet new IVDR requirements.

Innovation Speed

Presubmission Success for First-in-Class Robotic Surgical Platform

Managed FDA Presubmission interactions to clarify clinical evidence requirements for a breakthrough robotic technology.

Risk Management

Bio-compatibility Strategy Redesign for Implantable Drug-Delivery Systems

Rationalised testing strategies according to ISO 10993 to significantly reduce submission response times.

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