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Costa Rica medical device & IVD approval process
Medical device manufacturers who want to enter the Costa Rican market need to obtain approval from the Costa Rican Ministry of Health. There are a
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Costa Rica Ministry of Health Overview
The Costa Rican Ministry of Health is responsible for regulating the healthcare industry in Costa Rica. It also acts as the regulatory agency for
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Learn about the Costa Rican regulations which apply to medical devices
Costa Rica Medical Device Regulations
All documents were published by the Costa Rican Ministry of Health and are in PDF format. The Costa Rica Ministry of Health updates their database of
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Learn about the Egyptian regulations which apply to medical devices
Egypt Medical Device Regulations
Egypt's Ministry of Health and the Committee on Registration of Medical Devices have issued some important decisions regarding registration of
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MDR PMS and PSUR requirements white paper
PMS & PSUR requirements under the EU MDR
Medical device post-market surveillance (PMS) activities have already been described in the European Medical Device Directive (93/42/EEC) and are
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How ISO 13485:2016 Impacts Medical Device Companies
The new ISO 13485 revision is finally here and, for medical device manufacturers, this is big news. You probably have plenty of questions about how
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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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Understanding Europe's New Medical Device Regulation - MDR 2017/745
You've probably heard that Europe's well-established medical device regulations are about to change. And you probably have a lot of questions. What
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Europe In Vitro Diagnostic Devices Regulation (IVDR) CE Marking Regulatory Process
In order to commercialize in vitro diagnostic (IVD) devices in the European Union , a CE Mark certificate is needed. This certification verifies that
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