Regulatory Compliance & Documentation

Navigating the regulatory landscape for medical devices is complex, but with my 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 (e.g., FDA 510(k), CE Marking under EU MDR, or PMDA in Japan) and classify your device accordingly based on risk, complexity, and intended use.

• Regulatory Documentation Preparation:We 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.