Choosing the correct pathway for submitting an application to get your product approved by the FDA can be...
Medical Device
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...
Why Medical Device Design Reviews are Important
Design reviews are common practice across various industries when developing a product. The basic function of...
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