Resources

Get the latest white papers, process charts, and other resources about medical device regulatory affairs, quality assurance, human factors, and cybersecurity requirements.

Register for our webinar: Post Market Surveillance & PMCF under the European MDR
WATCH NOW: PMS & PMCF under the European MDR
Post-market surveillance (PMS) is complex and often misunderstood by device manufacturers. Europe's new Medical Devices Regulation (MDR) adds to the
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14971 risk management webinar
WATCH NOW: 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 major medical device markets.
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CER Complience webinar EMERGO 2018
WATCH NOW: Ensure Your CER Complies with MEDDEV 2.7/1 v4
Since the publication of MEDDEV 2.7/1 rev4 and the Medical Devices Regulation (MDR), clinical data is under heavy scrutiny by Notified Bodies and
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Clinical data and post-market compliance under the MDR
Clinical data and post-market compliance under the MDR
Europe's new Medical Devices Regulation (MDR) emphasizes a life-cycle approach to medical device risk management. To support this approach, the MDR
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Practical implications of the new EU MDR and ISO 14971 on post-market surveillance
The Final Draft International Standard (FDIS) of the 3rd Edition of ISO 14971 is now in its final stages and is expected to be published in August of
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Watch our recent webinar on Medical Device Approval in Japan
WATCH NOW: Japan's Medical Device Approval Process
Japan's medical device market is one of the most robust markets in Asia, but its regulatory system can be confusing. Before deciding to sell your
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WATCH NOW: Medical Device Registration in Mexico
Mexico is one of the largest medical device importers in the world, making it an attractive market for foreign companies. The Federal Commission for
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KSA webinar January 2019
WATCH NOW: Medical Device Registration Requirements in Saudi Arabia
Recorded on January 22, 2019 The Kingdom of Saudi Arabia (KSA) is the largest market in the GCC region and relies on international imports for
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How device companies can prepare for a no-deal Brexit
Impact of a No-Deal Brexit
Emergo’s regulatory experts in Europe are closely monitoring developments in British Parliament to assess how potential Brexit outcomes could affect
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