As the digital age continues to advance at an amazing pace, healthcare and medical devices have managed to...
PMS
Global Regulators publish Good Machine Learning Practices (GMLP)
It is no secret that AI/ML medical devices are under a special spotlight by international regulators this...
FDA One Step Closer to Approving EUA for COVID Vaccine for Children Ages 5 – 11
So many parents, who have been on a continuum of anxiousness since the beginning of the pandemic, were finally...
Cosmetics vs Drugs: Registering with the FDA
Registering a cosmetic product with the FDA is simple, so simple it is not even required by the FDA. The...
GMP’s for Cosmetics
Good Manufacturing Practices, or GMP’s, are well known for people in the medical device and pharmaceutical...
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...
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