EU Archives

Reporting Timelines for Adverse Events

When an event occurs related to a medical device there is the need to determine if it qualifies as an adverse event...

A concept similar to the FDA’s Design History Files, the EU Technical File is a collection of documents related to the...

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 correct pathway for submitting an application to get your product approved by the FDA can be...

‌ Are Managers Equipped – in terms of skills, competencies and courage to lead a digital transformation? ...

‌ Our clients have extensive experience and familiarity with CLIC, but for many of you out there, it is a new...

‌ As communication and travel have become easier, companies that were once destined to serve only a small area...

‌ The pandemic has changed quite a bit about our way of life. Despite how much has changed, kids will always be...

‌ Founded in 2008, “October 15 is Global Handwashing Day a global advocacy day dedicated to increasing awareness...

‌ Being non-compliant in even a small detail of a regulation can result in the need to perform a recall. For...

‌ Post-Market Surveillance (PMS) is a common part of Medical Device Regulations across the world. Most major...

‌ Design reviews are common practice across various industries when developing a product. The basic function of...