Medical Device

Project Overview

Medical Services from Hema Handels GmbH help companies bring, source, license, and manage medical devices and healthcare products in regulated markets. We combine compliance, quality systems, sourcing, logistics, and post-market surveillance into a streamlined, end-to-end service.

The Challenge

Entering and operating in the medical device ecosystem—especially in Europe under MDR—requires navigating complex classification, technical documentation, notified body interaction, supply chain traceability (UDI/EUDAMED), quality management (ISO 13485), and ongoing vigilance. Fragmented sourcing and inconsistent compliance increase time-to-market and risk.

Core Services

• Device classification & CE/MDR entry support

• Quality Management System alignment (ISO 13485)

• Clinical evaluation & technical documentation

• Notified Body engagement & certification coordination

• UDI registration & EUDAMED setup

• Compliant sourcing & logistics

• Post-market surveillance & vigilance

• IP/licensing facilitation and strategic consultation

Final Results

Clients gain compliant, faster market access with reduced regulatory risk, reliable supply chains, traceable device distribution, and ongoing quality governance—turning complexity into operational confidence.