The new European Union regulation for medical devices, EU MDR 2017/745, went into effect only recently and...
EU MDR
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...
Lost in Translation: Regulating Medical Devices Around the World
In the United States, medical devices are regulated by the FDA. In the European Union, medical devices are...
Choosing the Right Path for an FDA Submission
Choosing the correct pathway for submitting an application to get your product approved by the FDA can be...
Are Managers Equipped to Lead a Digital Transformation?
Are Managers Equipped – in terms of skills, competencies and courage to lead a digital transformation? ...
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...
Ready to learn more about working with us?
