Resources

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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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Brazil's medical device regulatory update
In recent years, ANVISA released numerous regulatory updates to make Brazil a more accessible medical device market. Currently, the medical device
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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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MDR and Annex XIV: the Crucial Role of Clinical Evaluation Reports
Learn how to build an MDR compliant clinical evaluation process, the minimum content requirements of the CEP and their implications, the criteria for
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Understanding the EU IVDR white paper by Emergo by UL
Applying Human Factors Engineering (HFE) to in vitro diagnostic (IVD) products under the European IVD Regulation (IVDR)
Yvonne Limpens and Brenda van Geel from Emergo by UL’s Human Factors Research & Design (HFR&D) team will share insights about the upcoming
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Two people reviewing documents in a lab
Clinical data and post-market compliance under the MDR
Gain insights from Emergo’s medical device clinical research team on the role of PMCF studies in MDR compliance and what it takes to conduct a PMCF
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Illustration of a calendar with one date circled
Preparing for the EU MDR Date of Application
The EU Medical Devices Regulation (MDR) Date of Application (DoA) is imminent. Do you understand what your regulatory obligations will be as of May
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The EU MDR and human factors engineering (HFE) requirements for post-market surveillance (PMS)
The EU Medical Devices Regulation (MDR) includes specific requirements for post-market surveillance (PMS), calling on medical device manufacturers to
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Illustration of a calendar with one date circled
Clinical Evaluation Reports (CER) for Medical Devices
The scrutiny of clinical evaluations by Notified Bodies has increased with the EU Medical Devices Regulation 2017/745 (MDR). This scrutiny leaves
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