51ÁÔÆæ

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 51ÁÔÆæ Radio, host Erika Porcelli and guest Steve Cox, a 51ÁÔÆæ Senior Consultant, cover the business strategy of outsourcing surveillance in both the...

In this episode of 51ÁÔÆæ Radio, host Erika Porcelli and guest Susan Schniepp, Distinguished Fellow at 51ÁÔÆæ, 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.

In this episode of 51ÁÔÆæ Radio, host Erika Porcelli and guest Lisa Michels, General Counsel & Regulatory Affairs Expert at 51ÁÔÆæ, examine the FDA's proposed regulatory framework...

Devicor, the leading breast biopsy device manufacturer, engaged 51ÁÔÆæ to build a clinical evaluation process.