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Brazil registration webinar 2018
WATCH NOW: Brazil ANVISA Medical Device Registration
Brazil’s medical device industry faced a number of challenges in recent years: a complex regulatory process created long delays for approvals and a
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WATCH NOW: Overview of the MDSAP Certification Process
WATCH NOW: Overview of the MDSAP Certification Process
The Medical Device Single Audit Program (MDSAP) offers a way to streamline the pre- and post-market audit process required by medical device
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Medical device registration in China webinar
NMPA medical device registration requirements in China
China represents a vast market for medical devices, but its regulatory system can be difficult to navigate. A recent report published by China’s
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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The European Medicines Agency (EMA) has recently issued draft guidance on Drug Device Combinations (DDC) that calls for usability studies, to come
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MDR and Human Factors – get ready for transition
The three-year transition period from MDD to MDR comes to an end on May 26th 2020. Among the many regulatory changes, the role of human factors is
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Register for our free webinar on choosing or changing your EU Notified Body
WATCH NOW: How to Select or Change Your EU Notified Body
European Notified Bodies are under intense scrutiny by Competent Authorities, and that oversight has filtered down to their clients. A few years ago
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EU mdr delay
MDR Transition: Countdown to compliance
When the European Medical Devices Regulation 2017/745 (MDR) takes effect, it will transform the regulatory system that governs the world’s second-
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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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Emergo MDR webinar October 2017
WATCH NOW: The new European Medical Devices Regulation (MDR 2017/745)
The first major revision to device regulations since 2007 has been released and the changes are significant. Although the MDR won't take effect for a
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