Colombian Regulatory Approval Process for Medical and IVD Devices
This process chart illustrates the INVIMA approval process per device classification in Colombia and is available for download in the Regulatory Affairs Management Suite (RAMS).
Conducting a Medical Device PMCF Study
In this free webinar, you’ll 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 study that should be acceptable to all stakeholders.
Hong Kong Regulatory Approval Process for Medical and IVD Devices
This process chart illustrates the MDD approval process per device classification in Hong Kong and is available for download in the Regulatory Affairs Management Suite (RAMS).
Mexico Medical Device and IVD Regulatory Approval Process
COFEPRIS regulatory approval process chart per device classification in Mexico is available for download in our Regulatory Affairs Management Suite (RAMS).
Marketing Medical Devices in the Post-Brexit Era: Working with a UK Responsible Person (UKRP)
The UK's withdrawal from the European Union has major ramifications for medical device manufacturers, including in-country representation requirements for companies selling their devices in Great Britain.
Brazil ANVISA Medical Device Regulations
This process chart shows Brazil's medical device regulatory approval process and is free to download in the Regulatory Affairs Management Suite (RAMS).
Risk Management According to EN ISO 14971:2012
Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical device markets.
ISO 14971:2019 and the Current State of Risk Management
This webinar is intended to highlight some of the key areas where the standard was changed technically, and where guidance was either introduced or expanded.
PMS & PMCF Under the European MDR
Many companies will need to maintain more robust PMS procedures and perform more PMCF studies to meet their Notified Body’s expectations. In this free webinar, we will discuss new European PMS and PMCF requirements.
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 26, 2021?