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Bookmark or Share- Emergo by UL | Medical Device, IVDR Compliance and Human FactorsEmergo by UL is a leading consulting firm specializing in global regulatory compliance and human factors for products in the medical industry. Our comprehensive services are designed to help you achieve and maintain regulatory and commercial success. Contact us.
- Japan Medical Device and IVD Regulatory Consulting | Emergo by ULEmergo can assist medical device companies with QMS compliance including Japan Ordinance 169 and the pharmaceuticals and medical devices Act (PMD Act). Our consulting team in Tokyo delivers local expertise and support for companies seeking PMDA approval in Japan.
- UDI Compliance Consulting for Medical Devices | Emergo by ULUDI compliance requires a significant effort on the part of manufacturers. Emergo has carefully followed the development of UDI rules in both the US and international markets and has the expertise and resources to help you establish compliance processes to meet US FDA UDI requirements.
- Brazil Market Access for Medical Devices and IVDs | Emergo by ULLearn what it means to choose Emergo by UL as your independent Brazil Registration Holder (BRH) for foreign medical device companies selling in Brazil.
- Our Services | Emergo by ULEmergo has been helping medical device and IVD companies with regulatory compliance and market entry since 1997. We maintain offices in 25+ countries, offering a wide range of compliance services, including regulatory strategy, device registration, quality management system compliance, and in-country regulatory representation.
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