Medical Device Regulatory Consulting and Market Access

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

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The US FDA 510(k) Clearance Process

This short video shows you what it takes to prepare and submit a medical device 510(k) to the US FDA.

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Mapping Cybersecurity Standards to FDA Guidance

Learn about medical device cybersecurity and how the UL 2900 standards correspond to FDA guidance in this one-hour recorded webinar.

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Meet the Emergo team at Hospitalar

Book an appointment with us at the show to discuss your questions about compliance in Brazil or other markets worldwide.

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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.

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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.