Post-market surveillance is necessary for ensuring compliance as regulatory bodies have the authority to impose...
Post-Market
EMMA International’s Body of Knowledge (BOK)
Do you enjoy all the content from EMMA International? We have good news for you! We are proud to announce that our...
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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