Ensuring Compliance for In Vitro Diagnostic (IVD) Devices

In Vitro Diagnostic (IVD) devices are essential for accurate disease detection and monitoring. Due to their impact on patient health, they must meet strict regulatory requirements to ensure safety and effectiveness.

Why IVD Compliance Matters

Regulatory bodies like the FDA (U.S.), IVDR (EU), and MHRA (UK) set rigorous standards to protect public health. Non-compliance can lead to market rejections, legal issues, and reputational risks.

Key Compliance Areas

• Device Classification & Risk Assessment – Determines the applicable regulatory pathway.
• Regulatory Approvals – Includes FDA 510(k), PMA, De Novo, and EU IVDR compliance.
• Performance Evaluation – Clinical and analytical studies ensure accuracy and reliability.
• Quality Management System (QMS) – ISO 13485 certification for consistent quality.
• Labeling & Post-Market Surveillance – Ensures continued compliance and patient safety.

How Advena Medical Can Help

At Advena Medical, we simplify the regulatory process, guiding IVD manufacturers through approvals and compliance requirements.

Our Services Include:

• Regulatory strategy & risk assessment
• FDA & IVDR submission support
• Clinical study guidance
• ISO 13485 QMS implementation
• Post-market compliance & reporting

Let’s Get Started

Avoid delays and compliance pitfalls. Contact Advena Today to ensure your IVD device meets global standards seamlessly.