Medical Consultancy Services in Surat

We provide medical regulatory consultants. preparation and submission of regulatory documentation including: 1. Technical files 2. Design dossiers regulatory and technical review and consulting. preparation and submission of registration for product applications. clinical trial applications. medical device vigilance and reporting systems. regulatory and manufacturing compliance. Strategic and regulatory planning. auditing of quality & regulatory system to ensure compliance with required quality systems & regulations regulatory/quality gap analysis. interpretation of guidance documents and legislation. assistance with device labeling requirements. liaison with regulatory authorities. Provide medical device classification. Risk management (iso 14971)