MedEnvoy Global B.V., Leidschendam-Voorburg, Zweigniederlassung Zug

The company provides consolidated services to medium-sized companies in the healthcare and life sciences industry to meet local regulatory requirements in key international markets. The core activity includes in particular: Regulatory consulting and support for compliance with local regulations; Services as in-country representative and regulatory importer; Support for the approval and monitoring of medical devices (e.g. Premarket Approval, Post Market Surveillance); Consulting on compliance with international standards and regulations (e.g. ISO 13485, FDA-QSR); Support for the registration of medical devices in various countries (e.g. EUDAMED, Swissdamed). The company positions itself as a trusted partner for companies in the healthcare and life sciences industry to support them in navigating complex regulatory requirements.