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Post-Market
Reporting Adverse Events
Post-market surveillance is necessary for ensuring compliance as regulatory bodies have the authority to impose...
Culture and Medical Device Quality
Providing a quality product while meeting all quality standards set by regulatory bodies can often prove to be a...
Post-Market Reporting in the EU
With the implementation of the new Medical Device Regulation (MDR) 2017/745 in the European Union, a lot has...
CLIC©: A Self-Learning QMS?
Our clients have extensive experience and familiarity with CLIC, but for many of you out there, it is a new...
What to Look for in an Authorized Representative
As communication and travel have become easier, companies that were once destined to serve only a small area...
A Safe Halloween During Covid-19
The pandemic has changed quite a bit about our way of life. Despite how much has changed, kids will always be...
Global Handwashing Day
Founded in 2008, “October 15 is Global Handwashing Day a global advocacy day dedicated to increasing awareness...
Surviving A Recall
Being non-compliant in even a small detail of a regulation can result in the need to perform a recall. For...
Post-Market Surveillance for Medical Devices
Post-Market Surveillance (PMS) is a common part of Medical Device Regulations across the world. Most major...
Canada’s Amended Post-Market Surveillance for Medical Devices
Health Canada recently published SOR/2020-262 amending the Food and Drug Regulations and the Medical Devices...
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