Regulatory Compliance & Documentation

Navigating the regulatory landscape for medical devices is complex, but with our services, We ensure compliance with global standards, providing all necessary documentation to ensure smooth market entry.

• Regulatory Strategy & Guidance:We assist in determining the correct regulatory pathway and classify your device accordingly based on risk, complexity, and intended use.

• Regulatory Documentation Preparation:We help you to prepare comprehensive regulatory documentation, including Technical Files, Design Dossiers, Risk Management Files, and Clinical Evaluation Reports, to meet regulatory submission requirements for various markets.

• Device Classification:We assist in determining the appropriate classification for your medical device (Class I, II, III) according to FDA, EU, or other regulatory bodies.

• Post-Market Surveillance & Reporting: We help in setting up effective post-market surveillance systems and reporting mechanisms, ensuring ongoing compliance post-launch.