EU Archives

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 – 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...

‌ Organizations are under enormous pressure to better understand their customers and business. Companies, large...

‌ An EUA (Emergency Use Authorization) was, until recently, rarely given. With the start of the COVID-19...

‌ There can be a multitude of reasons why troubled projects are delayed in being abandoned or brought under...