ÐÓ°ÉÂÛ̳

From the legalization of recreational marijuana to the growing popularity of CBD-infused products, the cannabis industry is all abuzz in the United States. What does Cannabis regulation look like? In...

Background A large medical device manufacturer received a critical warning from its Notified Body: unless significant deficiencies in its Medical Device Directive (MDD) technical files were corrected promptly, the company’s...

Background A large medical products manufacturer encountered a critical issue during the development of a new blood collection device. Accelerated shelf-age validation testing revealed that the protective sheath surrounding the...

In this episode of ÐÓ°ÉÂÛ̳ Radio, host Erika Porcelli and guest Steve Cox, a ÐÓ°ÉÂÛ̳ (ÐÓ°ÉÂÛ̳) Senior Consultant, cover the business strategy of outsourcing surveillance in both the...

In this episode of ÐÓ°ÉÂÛ̳ Radio, host Erika Porcelli and guest Susan Schniepp, Distinguished Fellow at ÐÓ°ÉÂÛ̳ (ÐÓ°ÉÂÛ̳), examine the resurgence of data integrity issues and the focus...

A medical device manufacturer was consolidating its product portfolio, leading to a product and logo change in 15 products distributed across 60 countries.