When an event occurs related to a medical device there is the need to determine if it qualifies as an adverse event...
EU
EU Technical Files
A concept similar to the FDA’s Design History Files, the EU Technical File is a collection of documents related to the...
EU MDR: Importers
The new EU MDR 2017/745 is complex, to say the least. Depending on a company’s relationship to the medical device the...
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...
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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