Resources

All regulatory process charts are available to download from Regulatory Affairs Management Suite (RAMS).
Log into RAMS or create your free account to download this information.

LOG INTO RAMS

Get unlimited access to the latest white papers, process charts, and other resources about medical device regulatory affairs, quality assurance, human factors, and cybersecurity requirements.

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
Read More
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
Read More
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
Read More
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
Read More
Two human factors researchers wearing surgical masks observe a human factors study of a medical device occurring in an observation room.
Conducting Safe In-person Testing During COVID-19
The experts from Emergo by UL’s Human Factors Research & Design (HFR&D) team will share insights learned from creating a safe setting to
Read More
Understanding the EU IVDR white paper by Emergo by UL
Understanding Europe's New IVDR 2017/746
It's finally here. The European Commission's new In Vitro Diagnostic Regulation (IVDR 2017/746) will address several weaknesses of the IVDD and bring
Read More
Register: Eudamed Webinar July 2018
WATCH NOW: Eudamed Requirements under the EU MDR and IVDR
As it prepares to meet new regulatory requirements in Europe, the medical device community is also following developments about the European Database
Read More
EU IVDR readiness checklist from Emergo by UL
EU IVDR Readiness Assessment Checklist
Is your company ready for the implementation of the European In Vitro Diagnostics Regulation (IVDR)? Under the IVDR, in vitro diagnostic (IVD) device
Read More