Empowering Medtech Innovators in the European Market
Our Services
Development Expertise
MediB GmbH provides expert guidance in product development, CE certification, and regulatory strategy. We specialize in turning innovative ideas into compliant, market-ready products, allowing you to focus on growth and success.
CE Certification Support
Navigating the complex landscape of CE certification can be challenging. At MediB GmbH, we offer tailored support to ensure your products meet the necessary requirements, facilitating a smooth certification process.
Regulatory Strategy Consultation
Understanding and complying with EU regulations is essential for market entry. Our team at MediB GmbH simplifies EU regulations, providing strategic guidance to help you navigate the regulatory landscape with ease.
Authorized Representative (EC Rep): Your Trusted EU Presence
For non-EU manufacturers, appointing an Authorized Representative is a legal requirement under MDR and IVDR. MediB acts as your dedicated EC Representative, ensuring full compliance with EU regulations while safeguarding your independence and flexibility.
Expert Guidance for MedTech Growth in Europe
Partner with MediB for a seamless journey to the European MedTech market. Our comprehensive program combines regulatory expertise, business strategy, and dedicated EC Representation to ensure compliance and drive growth. Trust MediB to handle the complexities while you focus on advancing your innovations.