Medical Device Regulatory Consulting and Market Access

More than 2,800 medical device and IVD companies worldwide depend on Emergo.

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Avoid costly product expirations

RAMS-TRACK is a powerful software tool that simplifies device registration and certificate tracking. With all your registrations in one place, preparing renewals is easier and faster than ever.

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Updated Chart: Medical Device Registration in Mexico

Our Mexico regulatory chart illustrates the COFEPRIS registration process for medical devices, updated to reflect recent regulatory changes.

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Updated Chart: Medical Device Registration in Saudi Arabia

Our Saudi Arabia regulatory chart illustrates the SFDA registration process for medical devices, updated to reflect recent regulatory changes.

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Recorded Webinar: FDA De Novo Process

The recorded version of our May webinar about the US FDA de novo process for novel medical devices is now available.

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Risk Management in the New Regulatory Environment

In this new white paper, Mark Leimbeck discusses how the medical device regulatory landscape is changing for risk management.

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Emergo has the medical device consulting expertise to help grow your business worldwide

Emergo is a single resource for helping you access the largest and fastest growing markets worldwide. With local offices in 20+ countries, we offer the expertise to help you research new markets, comply with national medical device and IVD regulations, maintain control of your device registrations and partner with high quality distributors. Learn how we can help you grow.

  • Clinical Consulting
    Pre-clinical strategy, clinical evaluation reports and post market studies.
  • Device Registration
    Tap our expertise registering thousands of devices in 20+ markets globally.
  • QMS Compliance
    Implementation and internal auditing for ISO 13485, FDA QSR and more.

See how Emergo helps companies from {{country}} with medical device regulations worldwide.

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Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Learn more here.