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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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Europe CE Marking Regulatory Process for Medical Devices
In order to commercialize medical devices in the European Union , a CE Mark certificate is needed. This certification verifies that a device meets
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European IVD Regulatory Approval Process
IVD devices (In Vitro Diagnostics) are a subset of medical devices primarily used for to testing human fluids such as blood, tissue or urine in a
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How device companies can prepare for a no-deal Brexit
How device companies can prepare for a no-deal Brexit
As Brexit Day approaches, the outcome of the UK’s planned withdrawal from the EU seems more uncertain than ever. One thing is definitive: a no-deal (
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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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Register for our free webinar on Transitioning to ISO 13485:2016
WATCH NOW - What You Need To Know about ISO 13485:2016
ISO 13485:2016 is the first major revision to the global quality system standard since 2003. In this one hour recorded webinar we cover the major
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MDR and Human Factors – get ready for transition
The transition period from MDD to MDR comes to an end on May 26th, 2021. Among the many regulatory changes, the role of human factors is greatly
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EU MDR Readiness Checklist
EU MDR Readiness Assessment Checklist
How prepared is your company for compliance to the European Medical Devices Regulation (MDR)? Medical device CE Marking requirements will change
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