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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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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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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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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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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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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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