Are Managers Equipped – in terms of skills, competencies and courage to lead a digital transformation? ...
Guidance
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...
Managing Organizational Data in the Regulated Industries
Organizations are under enormous pressure to better understand their customers and business. Companies, large...
Preparing for the End of Your EUA
An EUA (Emergency Use Authorization) was, until recently, rarely given. With the start of the COVID-19...
Electronic Signatures Under 21CFR§11
In the work from home era, we all realized how important it is to digitize our important documents and what a...
FDA Guidance Documents
If you are in the Life Sciences Industry you have heard of FDA Guidance Documents, and specifically, if you are in a...
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