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Regulatory Affairs And Quality Management

Regulatory Services

At RMT, we not only create medical-grade products but also help bring them to reality through comprehensive regulatory support. From the preparation of technical files to ensuring Quality Management System (QMS) compliance, we help you navigate through the complex regulatory landscape to accelerate the commercialization of your product.

Technical File Preparation

At Revive Medical Technologies, we specialize in preparing comprehensive technical files for CE and FDA approval, catering to medical devices across all risk classifications. Our approach integrates seamlessly with ISO 13485 quality management systems, streamlining the approval process & enhancing product quality.

Clinical Evaluation Report (CER)
Biological Evaluation Reports (BER)
Implementation of Quality Management System
Technical File Preparation
Clinical Evaluation Report (CER)
Biological Evaluation Reports (BER)
Implementation of Quality Management System