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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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Watch our recent webinar on the European In Vitro Diagnostic Devices Regulation
WATCH NOW: Europe's New IVDR 2017/746
Within the next few years, the regulatory landscape will change dramatically for IVD companies selling in Europe. The current In Vitro Diagnostic
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Conducting a medical device PMCF webinar
Conducting a Medical Device PMCF Study
The EU Medical Devices Regulation (MDR 2017/745) emphasizes Post-Market Clinical Follow-up (PMCF) studies for collecting structured post-market data
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Register for our webinar: Post Market Surveillance & PMCF under the European MDR
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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MDR and Combination Products
Combination products, usability, and the EU MDR
The European Medicines Agency (EMA) has recently issued draft guidance on Drug Device Combinations (DDC) that calls for usability studies, to come
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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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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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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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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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