3 services found
Emergo by UL Services
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Medical Device Market Access Consulting
Emergo 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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Medical Device Registration Services
Commercializing your medical device first requires you to obtain registration and approval from regulatory agencies in each country where you plan to sell your device. Device registration requirements can vary significantly from country to country, which can create compliance challenges for companies pursuing multiple-market strategies. Depending on where you plan to sell your device(s), successful registration may involve substantial effort to meet ...
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Independent Regulatory Representation Services for Medical Device Companies
Medical device regulations in most countries require foreign manufacturers to appoint an in-country representative. Your representative acts as your liaison to regulatory authorities and assists with device registrations and vigilance/adverse event reporting. It’s important to choose a representative who is familiar with the regulatory requirements for your product to act in the best interest of your ...
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Post-Market Surveillance Services
Regulators in most medical device markets require registrants to meet post-market surveillance (PMS) obligations to maintain compliance. However, PMS rules can vary between different medical device markets, requiring manufacturers to develop tailored rather than one-size-fits-all approaches. With deep expertise in post-market surveillance requirements, Emergo is equipped to act as your compliance partner long after your device goes on the market. We can ...