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Utilizing RAMS for efficient medical device RA/QA management
Medical device and IVD manufacturers who use or are considering using the Regulatory Affairs Management Suite (RAMS) digital platform will benefit
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Emergo webinar - wireless device requirements 2019
WATCH NOW: Navigating Regulatory Requirements for Wireless Medical Devices
Cellular technology adds exciting new possibilities for healthcare but can also bring regulatory burden. When you incorporate a wireless module into
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HFRD An intensive look at potential use errors webinar
An intensive look at methods for identifying potential use errors
To ensure that medical device and combination products can be used safely and effectively, it is incumbent upon manufacturers to identify and
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Register for our free webinar on Risk Management changes in ISO 13485:2016
WATCH NOW - Risk Management Changes in ISO 13485:2016
Risk management requirements for medical device manufacturers will expand significantly with the publication of ISO 13485:2016. Manufacturers will
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WATCH NOW: Sterile Medical Device Packaging Requirements to EN ISO 11607
Medical devices delivered in a sterile state must be designed, manufactured, and packed to ensure they are sterile when placed on the market. However
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Wireless module medical device compliance webinar
Market-specific requirements for medical device wireless module compliance
In our first wireless compliance webinar , we highlighted the two main pathways to medical device wireless compliance: modular approval and system
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webinar - risk management landscape April 2018
WATCH NOW: Risk Management for Medical Devices in the New Regulatory Environment
Regulatory expectations for medical device risk management are evolving toward the need for “mature” systems and processes. Recent standard revisions
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Human factors SAMD webinar
Human factors consideration as it applies to Software as Medical Device (SaMD)
Most medical devices today include physical user interface elements… dials, knobs, levers, and other similar components used to control the device.
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WATCH NOW: Human Factors Engineering for Combination Products
Human factors engineering (HFE) efforts are becoming a regulatory necessity for medical device companies in markets around the world. Combination
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