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The healthcare industry is changing and we have the breadth of expertise to help you evolve with it.

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

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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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Conducting a Medical Device PMCF Study

In this free webinar, you’ll gain insights from Emergo’s medical device clinical research team on the role of PMCF...
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Marketing Medical Devices in the Post-Brexit Era: Working with a UK Responsible Person (UKRP)

The UK's withdrawal from the European Union has major ramifications for medical device manufacturers, including...
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Risk Management According to EN ISO 14971:2012

Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in...
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Human Factors Considerations as they Apply to Software as a Medical Device (SaMD)

Insights and suggestions for designing SaMDs, explore existing considerations for human factors guidance regarding SaMD,...
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MDR and Human Factors – Get Ready for Transition

The transition period from MDD to MDR comes to an end on May 26th, 2021. Among the many regulatory changes, the role of...
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Latest FDA Expectations for Conducting Human Factors Validation Tests of Combination Products

FDA outlines its fundamental expectations for applying human factors engineering (HFE) to combination products in its...
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ISO 14971:2019 and the Current State of Risk Management

This webinar is intended to highlight some of the key areas where the standard was changed technically, and where...
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PMS & PMCF Under the European MDR

Many companies will need to maintain more robust PMS procedures and perform more PMCF studies to meet their Notified...
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Extended MDR Date of Application: Optimizing Your PMS and Clinical Activities

In this one-hour webinar, we will focus on key compliance issues manufacturers should focus on in order to fully utilize...
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Clinical Evaluation Reports (CER) for Medical Devices

This webinar provides an overview of manufacturer responsibilities for clinical evaluation under the MDR. The scrutiny...
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Preparing for the EU MDR Date of Application

The EU medical devices regulation (MDR) date of application (DoA) is imminent. Do you understand what your regulatory...
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NMPA Expectations for Applying Human Factors Engineering (HFE) to Medical Devices

During the webinar, the presenters will cover key HFE considerations when marketing medical devices in China, US and...
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