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A platform of digital products to improve, simplify and automate RA/QA activities

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Emergo by UL's new human factors tool - provides training, tools, and resources.

Our software tools offer digital regulatory monitoring for medical device compliance and access to human factors engineering tools.

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RADAR : Market Access Newsletter

Stay informed with the most read RA/QA medical device newsletter.

TalkingPoints : Human Factors Newsletter

TalkingPoints is a round-up of news, insights, and resources about human factors and usability for medical devices, IVDs, combination products, and more.

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United States

From 510(k) consulting to QSR implementation, we can help you obtain FDA clearance for your medical device.

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We work with clients to solve their biggest challenges in regulatory affairs, quality assurance, and device risk mitigation.

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Certificate of Free Sale (CFS) for Medical Device Exports

Emergo helps medical device companies secure Certificate of Free Sale (CFS) for medical device exports to countries...

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FDA Q-Sub Consulting and Pre-Sub Guidance for Medical Devices

Our US consulting team has extensive experience with the FDA Q-Sub process for medical devices. We can assist you with...

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FDA QSR Audits for Medical Device and IVD Companies

Learn how we can assist medical device and IVD companies in complying with QSR audits and implementing a quality...

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FDA QSR Consulting (21 CFR 820) for Medical Device Manufacturers

Emergo by UL offers FDA QSR consulting for medical device and IVD companies to help support successful 21 CFR Part 820...

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FDA Submission Consulting for Medical Devices and In Vitro Diagnostics (IVDs)

FDA submission consulting services for medical device and IVD companies. Get help with US FDA registration from Emergo...

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ISO 13485:2016 Consulting and Gap Analysis

ISO 13485:2016 is coming! Let Emergo help you transition from ISO 13485:2003 or ISO 13485:2012. Local offices throughout...

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ISO 14971 Risk Management Consulting for Medical Device Companies

ANSWERED ON THIS PAGE: What does ISO 14971 require? How do I implement ISO 14971? How do I apply the risk...

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Local Authorized Representative for Medical Device Manufacturers

Emergo by UL can act as an independent, local authorized regulatory representative for medical device and IVD...

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Medical Device Post-market Surveillance

Regulatory compliance doesn’t end when your device goes to market. We design compliance solutions informed by a...

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Medical Device UDI (Unique Device Identification) Consulting and Training

ANSWERED ON THIS PAGE: How does the US FDA UDI system work? When must we comply with UDI system requirements? Which...

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US FDA 510(k) Consulting for Medical Devices and IVDs

Learn about the FDA pre-market notification 510(k) submission process, US FDA 510(k) consulting for medical device...

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US FDA Agent Representation for Medical Device and IVD Companies

Appoint Emergo as your registered US FDA Agent representation and learn about our responsibilities as the liaison...

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